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Administrative data

Description of key information

No studies with n/i-C13-C15-aldehydes regarding local effects on the skin and eye are available, but data from a structurally closely related substance (n/i-undecanal) suggest that the aldehydes are irritating to the skin, but nor irritating to the eyes. No studies on respiratory irritation are available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 26 FEB 1985 to 5 MAR 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Baisc data given: comparable to guidelines Read-across hypothesis: for details please see read-across report in IUCLID section 13
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: no substance composition or purity stated, no statement given concerning results for day 14 observation
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits Limited, Lea Valley, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 to 2.43 kg
- Housing: suspended metal cage, individually
- Diet: standard laboratory diet (Rabbit Diet, A. W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 45-55
- Air changes (per hr): ~ 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to guideline OECD 404

READING TIMES: 1, 24, 48, 72 hours after removal of the patches, if irritation persisted further observations were made 7 days and 14 days following removal of the patches
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
: total scores for erythema and edema divided by 6
Time point:
other: 24 and 72 h
Score:
5.5
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all three animals; individual scores per animal: 3/3/2.67
Time point:
other: 24-48-72 h
Score:
ca. 2.89
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: reactions were extending beyond the site of application
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all three animals; individual scores per animal: 2/3.34/3.34
Time point:
other: 24-48-72 h
Score:
ca. 2.89
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: reactions were extending beyond the site of application
Irritant / corrosive response data:
Additionally to erythema and edema desquamation was seen in two animals at 72 h. At day 7 hyperkeratinization with some flaking from affected areas was also evident in all three animals.

Read-across justification: for details please see read-across report in IUCLID section 13

After patch removal:

- 1 h: very slight erythema (score 1/1/1) and very slight or slight edema (score 2/2/1), with reactions extending beyond application site

- 24 h: moderate erythema (score 3/3/3) and slight or severe edema (score 2/4/4), with reactions extending beyond application site

- 48 h: moderate erythema (score 3/3/3) and slight edema (score 2/2/2), with reactions extending beyond application site

- 72 h: well defined or moderate erythema (score 3/3/2) and slight edema (score 2/2/2), with reactions extending beyond application site and desquamation observed in 2 animals

- 7 days: very slight or well defined erythema (score 1/2/1) and very slight edema (score 1/1/1), with reactions extending beyond application site and hyperkeratinization with some flaking of affected areas in all animals

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test substance was irritating to the skin of rabbits.
Executive summary:

3 New Zealand white rabbits were dermally exposed to the undiluted test substance (purity: not stated; 0.5 mL fluid were soaked into 6.25 cm² gauze patch) according to testing guideline OECD 404. After 4 h of semiocclusive exposure and at reading times 24, 48 and 72 hours after patch removal the test substance caused well-defined to severe erythema (mean score: 2.89; individual scores per animal: 3/3/2.67) and slight or severe edema (mean score: 2.89; individual scores per animal: 2/3.4/3.4). After 72 h two animals out of three showed desquamation, after 7 days all animals showed hyperkeratinization with some flaking from the affected areas. The test item thus revealed irritating effects.

This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 4 MAR 1985 to 11 MAR 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines Read-across hypothesis: for details please see read-across report in IUCLID section 13
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: initial body weights of the test animals differ slightly to much
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.24 to 2.87 kg
- Housing: suspended metal cages, individually
- Diet: standard laboratory diet (Rabbit Diet, A .W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 45-61
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The treated and control eyes the animals remained unwashed throughout the observation period.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: basically according to guideline OECD 405

TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)

Reeding times: 1, 24, 48 and 72 hours following treatment (if irritation persisted at the 72 h observation additional readings were made at 7, 14 and 21 days)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
of all animals; individual scores per animal: 1/0.33/1
Time point:
other: 24-48-72 h
Score:
0.78
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all animals; individual scores per animal: 1/0/1
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Observations at reading times (scores are given for animal#1/#2/#3) :
- 1h: diffuse crimson red colouration of the conjunctivae accompanied by slight swelling in all three animals (conjuctivae redness 2/2/2; chemosis 2/2/2; discharge 2/2/2; all other scores in all animals are 0)
- 24 h: reduction in the level of reaction in all three animals (conjuctivae redness 1/1/1; chemosis 1/0/1; discharge 0/0/0; all other scores in all animals are 0)
- 48 h: the reactions had already ameliorated completely in one rabbit (conjuctivae redness 1/0/1; chemosis 1/0/1; all other scores in all animals are 0)
- 72 h: (conjuctivae redness 1/0/1; chemosis 1/0/1; all other scores in all animals are 0)
- 7 days: the remaining two rabbits are fully recovered (all scores are 0)

Read-across justification: for details please see read-across report in IUCLID section 13

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions tested the test item is not irritating to eyes of rabbits.
Executive summary:

Irritation of the eye was tested in 3 New Zealand white rabbits according to guideline OECD 405. 0.1 mL of test item (purity: not stated, undiluted, not washed out) were instilled into the lower conjunctival sac of the right eye of each rabbit. At relevant reading times (24, 48 and 72 h after test material instillation) slight irritating effects on the conjunctiva (redness (mean score: 0.78; indivial scores per animal: 1/0.33/1)) and chemosis (mean score: 0.67; individual ) were observed in all animals. All effects were fully reversible within 7 days and no effects on the cornea or iris were observed, thus the test item is not irritating to the eye.

This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

3 New Zealand white rabbits were dermally exposed to the undiluted test substance (n/i-undecanal; purity: not stated; 0.5 mL fluid were soaked into 6.25 cm² gauze patch) according to testing guideline OECD 404. After 4 h of semiocclusive exposure and at reading times 24, 48 and 72 hours after patch removal the test substance caused well-defined to severe erythema (mean score: 2.89; individual scores per animal: 3/3/2.67) and slight or severe edema (mean score: 2.89; individual scores per animal: 2/3.4/3.4). After 72 h two animals out of three showed desquamation, after 7 days all animals showed hyperkeratinization with some flaking from the affected areas. The test item thus revealed irritating effects.

Irritation of the eye was tested in 3 New Zealand white rabbits according to guideline OECD 405. 0.1 mL of test item (n/i-undecanal; purity: not stated, undiluted, not washed out) were instilled into the lower conjunctival sac of the right eye of each rabbit. At relevant reading times (24, 48 and 72 h after test material instillation) slight irritating effects on the conjunctiva (redness (mean score: 0.78; individual scores per animal: 1/0.33/1)) and chemosis (mean score: 0.67; individual scores per animal: 1/0/1) were observed in all animals. All effects were fully reversible within 7 days and no effects on the cornea or iris were observed, thus the test item is not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 n/i-undecanal is irritating to the skin (category 2), based on the observed moderate irritation in all three animals on three consecutive days. This result is also expected for n-/i-C13 -C15 -aldehyde which should be classified accordingly (skin irritant category 2).

N/i-undecanal caused a slight irritation of the eye without reaching a level that requires classification according to criteria in Regulation (EC) No 1772/2008. This is also expected for n/i-C13 -C15 -aldehyde which, therefore, is not considered to require classification for eye irritation.

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