Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin Irritation

Not irritating to the skin

 

Ocular Irritation

Not irritating to eyes

 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is a respiratory irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct. 2, 1990- Oct. 23, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Justification for type of information:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week

IN-LIFE DATES: From: Oct. 2, 1990 To: Oct. 23, 1990
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: control area on each test animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml undiluted
Duration of treatment / exposure:
4 hrs
Observation period:
21 days
Number of animals:
6 - 3 males, 3 females
Details on study design:
TEST SITE
- Area of exposure: An 8 x 8 cm dorsal area of the trunk was clipped. Part of this area was used as a control.
- % coverage: An approximately 2.5 x 2.5 cm area of the trunk was covered.
- Type of wrap if used: Test material was placed beneath two single layers of surgical gauze which were secured with non-irritating adhesive tape. Trunks of the animals were wrapped with semi-permeable dressing held in place with non-irritating adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with room temperature tap water and wiped with a wet cloth.
- Time after start of exposure: 4 hrs


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.22
Max. score:
2
Reversibility:
other: 21 days
Remarks on result:
other: Fully reversible in all but 2 animals (very minor redness observed)
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
All animals showed very slight erythema/eschar at the 3-4 hrs observation. This persisted in all animals until at least day 10, with some animals showing an increase to a score of 2. The erythema/eschar did not resolve in two of the animals by the end of the experiment at day 21. Two animals showed very slight edema at the .75 hr observation, with all animals showing this at the 24 hr observation. The edema symptoms did not worsen, and resolved in all animals by day 21.
Other effects:
No other effects were seen in any animal at any observation.

Animal

Observation

Hours

Days

3-4

24

48

72

7

10

14

17

21

9918-M

Erythema/eschar

1

1

1

1

1

0

0

0

0

Edema

0

1

1

1

1

1

0

0

0

9920-M

Erythema/eschar

1

1

1

1

1

1

1

1

0

Edema

0

1

1

1

1

1

0

0

0

9922-M

Erythema/eschar

1

1

1

1

1

1

1

1

1

Edema

1

1

1

1

1

1

0

0

0

9913-F

Erythema/eschar

1

2

2

2

1

1

1

1

0

Edema

0

1

1

1

1

1

0

0

0

9915-F

Erythema/eschar

1

1

1

1

2

2

1

1

0

Edema

0

1

1

1

1

1

0

0

0

9917-F

Erythema/eschar

1

1

1

2

2

2

1

1

1

Edema

1

1

1

1

1

1

1

1

0

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

This study examined the skin irritancy of MR Solvent to rabbit skin. 3 male and 3 female rabbits were exposed dermally to 0.5 ml of test substance for 4 hrs. Test substance was applied to a clipped dorsal area and the area occluded. After 4 hrs, the test areas were washed with tap water. Once the test substance was removed, the animals were scored for skin irritation. Additional observations were made at 24, 48, and 72 hrs, and 7, 10, 14, 17, and 21 days after removal. Animals exhibited very slight erythema and edema (score of 1) beginning at the first observation. By the 24 hr observation, some of the erythema scores had risen to 2, which reversed by day 10. All edema symptoms had resolved by day 21, however, two animals still had very slight redness on day 21. No other signs of skin irritation were seen. The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985/07/11 - 1985/07/31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: GLP.
Justification for type of information:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing used; 24 hour exposure
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles Rivers UK Ltd
-Sex: Male (10); Female (10)
- Age at study initiation: 6 weeks
- Weight at study initiation: Male: 125-135g; Female: 110-115g
- Housing: individually housed
- Diet (e.g. ad libitum): No. 1, expanded pelleted maintenance diet for rats and mice from Special Diet Services Ltd., ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6-day acclimatisation


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 58-90
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
Amount(s) applied (volume or weight): 2.0 ml
Concentration (if solution): neat
Duration of treatment / exposure:
On the day prior to application the trunk of each animal was clipped free of hair. For each treated animal, 2 mL/kg of BP83HF was applied to a patch of absorbent paper. The patch was applied to the trunk and held in place beneath a sleeve under a Poroplast bandage. The whole patch assembly was held in place with tape. The patches were left in position for approximately 24 hours. Patches were similarly applied to control animals with the omission of test material. To prevent the animals from gaining access to the sites of application (and hence possibly ingesting traces of test material), collars were applied around the animals heads for a further 24 hours (control and test animals).
Observation period:
Once per day for 14 days
Number of animals:
Control: (5) males; (5) female
2 ml/kg (converted 1.7 g/kg): (5) males; (5) females
Details on study design:
SCORING SYSTEM: Draize scale
- Dermal response observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks:
after 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible
Remarks:
after 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 0.2
Max. score:
2
Reversibility:
fully reversible
Remarks:
after 72 hours
Remarks on result:
other: Only one female rabbit displayed an erythema score of 2.0 at the 72 hour observation. Reversed in all other 9 animals.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.35
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
There were no animal deaths prior to study termination. Well-defined erythema was noted upon removal of the test patches in all animals exposed to BP83HF, generally persisting for a further 24 hours. Scab formation was subsequently observed on Day 5 and skin flaking was noted on Day 6 in all treated animals, persisting for a few days only in most animals. Plaster marks were noted on all test and control animals following patch removal; this is an artifact of the test procedure and is commonly seen in studies of this type. No other significant signs of ill health, behavioral change or reaction to treatment were noted.
Other effects:
The body weight gain of male rats was unaffected by treatment with the test material. A marginally larger overall weight gain was recorded for treated female rats when compared with the controls; this was considered to have arisen fortuitously and not related to treatment with BP83HF.

Post mortem examination of all animals killed at termination revealed an area of diffuse subcutaneous haemorrhage beneath the dorsal patch site in one male exposed to BP83HF. However, no other findings considered to be related to treatment were observed and no tissues were processed further for histopathological examination.

Post mortem examination of all animals killed at termination revealed an area of diffuse subcutaneous haemorrhage beneath the dorsal patch site in one male exposed to BP83HF. However, no other findings considered to be related to treatment were observed and no tissues were processed further for histopathological examination.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The average erythema score (24, 48, and 72 hours) was 1.35.   Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

In this study, 10 rabbits were exposed to 2.0 ml of BP83HF via an occlusive patch. Dermal responses were evaluated once a day for 14 days.  Skin irritation was scored according to the Draize method of scoring. At the 24 and 48 hour observations, all animals were noted with a well defined erythema.  Only one animal was noted with well defined erythema at the 72 hour observation.  After 72 hours, all animals were free of dermal irritation.  The average erythema score (24, 48, and 72 hours) was 1.35. This study was conducted to acceptable, well-documented scientific principles.  Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct. 1, 1990 - Oct. 4, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week

IN-LIFE DATES: From: Oct. 1, 1990 To: Oct. 4, 1990
Vehicle:
unchanged (no vehicle)
Controls:
other: the non-treated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water 30 seconds after start of exposure. The eyes of the remaining 6 animals were unwashed.
Observation period (in vivo):
72 hrs at which time no animals showed signs of irritation.
Number of animals or in vitro replicates:
9 animals total
3 males and 3 females were used in the unwashed eye experiment
3 males were used in the washed eye experiment
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water. The eyes of the remaining 6 animals were unwashed.
- Time after start of exposure: 30 seconds after start of exposure


SCORING SYSTEM: According to EPA guidelines 81-4


TOOL USED TO ASSESS SCORE: All animals were examined with 0.2% fluorescein sodium ophthalmic solution at the 24 hr observation . Since no fluorescein staining was seen in any animal, the examination was not repeated at later observations.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: unwashed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritant / corrosive response data:
All six of the unwashed animals showed redness (score of 1) at the 1 and 24 hr observations. The three females and one male also showed chemosis (score of 1) at the 1 hr observation. All symptoms were resolved at the 48 hr observation. All three washed animals showed redness (score of 1) at the 1 and 24 hr observation. These symptoms were also resolved by the 48 hr observation.
Other effects:
No other effects were observed in any animal at any observation.

Individual Eye Irritation Scores - Washed

Animal

1 hr

24 hrs

48 hrs

72 hrs

9960-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9962-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9964-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

Individual Eye Irritation Scores - Unwashed

Animal

1 hr

24 hrs

48 hrs

72 hrs

9954-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9956-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9958-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9957-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9959-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9961-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively.  The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0.  The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation.  Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985/07/22-1985/07/25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: GLP
Justification for type of information:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no 72 hour observation, but material demonstrated no irritation at 24 and 48 hours
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits
- Sex: 3 females
- Weight at study initiation: 2.4 to 3.0 kg
- Housing: Individually
- Diet (e.g. ad libitum): Guinea Pig Maintenance Diet, from Special Diet Services, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 46-71
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contra-lateral eye
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.1 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was introduced into one eye of each animal. The eyelids were held together for approximately one second, and then released to allow observation of the reaction of the animal.
Observation period (in vivo):
1, 24, and 48h post instillation and once per day on days 4 and 7. For each observation, reference was made to the contra-lateral (untreated) eye.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
SCORING SYSTEM: Draize scale for ocular irritation.

The presence of damage to the tissues of the eye was investigated by fluorescein staining at each observation except those on the day of exposure. Any ocular reactions not adequately described by the scoring system or in structures not mentioned were recorded in full. At the completion of the observation period the rabbits were killed by cervical dislocation.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: no irritation was noted after the 1 hour observation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritant / corrosive response data:
All animals exhibited a conjunctival redness score of 1 at the 1 hour time point. All irritation scores were zero at the 24 and 48 hour observation time points.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

This study was conducted to determine the potential of BP83HP to cause irritation to the eye in a rabbit model system. The eyes of six rabbits were instilled with 0.1 ml of BP83HP, neat. Ocular examinations occurred at 1h, 24h, and 48h post instillation. Ocular damage was assessed and scored according to the Draize method. All animals survived the exposure. There was slight irritation noted (conjunctivae score of 1) at the 1 hour observation point. There was no irritation at the 24 and 48 hour observations. The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.

There is no data available for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). However, data is available for structural analogues, C9-C14 Aliphatics (2-25% Aromatics) solvents and Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%). This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Skin Irritation

A key study (Sasol, 1990a) examined the skin irritancy of C9-C14 aliphatic solvents (2-25% aromatics) to rabbit skin. 3 male and 3 female rabbits were exposed dermally to 0.5 ml of test substance for 4 hrs. Test substance was applied to a clipped dorsal area and the area occluded. After 4 hrs, the test areas were washed with tap water. Once the test substance was removed, the animals were scored for skin irritation. Additional observations were made at 24, 48, and 72 hrs, and 7, 10, 14, 17, and 21 days after removal. Animals exhibited very slight erythema and edema (score of 1) beginning at the first observation. By the 24 hr observation, some of the erythema scores had risen to 2, which reversed by day 10. All edema symptoms had resolved by day 21, however, two animals still had very slight redness on day 21. No other signs of skin irritation were seen. The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

In a key study (DHC Solvents Chemie GmbH, 1985), 10 rabbits were exposed to 2.0 ml of the test material (Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)) via an occlusive patch. Dermal responses were evaluated once a day for 14 days.  Skin irritation was scored according to the Draize method of scoring. At the 24 and 48 hour observations, all animals were noted with a well-defined erythema.  Only one animal was noted with well-defined erythema at the 72 hour observation. After 72 hours, all animals were free of dermal irritation. The average erythema score (24, 48, and 72 hours) was 1.35. This study was conducted to acceptable, well-documented scientific principles. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Ocular Irritation

In a key eye irritation study (Sasol, 1990b), application of 0.1ml of C9-C14 aliphatic solvents (2-25% aromatics) to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively.  The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

A key study (DHC Solvents Chemie GmbH, 1985) was conducted to determine the potential of the test material (Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)) to cause irritation to the eye in a rabbit model system. The eyes of six rabbits were instilled with 0.1 ml of the test material, neat. Ocular examinations occurred at 1h, 24h, and 48h post instillation. Ocular damage was assessed and scored according to the Draize method. All animals survived the exposure. There was slight irritation noted (conjunctivae score of 1) at the 1 hour observation point. There was no irritation at the 24 and 48 hour observations. The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the test material were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is a respiratory irritant.

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) does not meet the criteria for classification for skin Irritation under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Ocular Irritation:

Based on available read across data, Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) does not meet the criteria for classification as ocular irritants under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Respiratory Irritation:

There are no studies that warrant classification as a respiratory irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).