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Diss Factsheets

Administrative data

Description of key information

in vivo rabbits, OECD 404, not skin irritant

in vivo rabbits, OECD 405, not eye irritant

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippischen Versuchstierzucht, Hagemann Gmbh
- Weight at study initiation: 2.4 kg
- Housing: individual cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40% r.F.
- Photoperiod (hrs dark / hrs light): 12hrs light/12 hrs dark
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: the left side of the animal was used as control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Observation period:
up to 8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 8x8 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water and/or olive oil
- Time after start of exposure: 1h

SCORING SYSTEM:
the grade of erythema and edema formation in proof area after 24 and 72 are averaged over the experimental animals. the sum of the four values is divided by 2, and produces the primary skin irritant score. The findings of 1h, 48h, and 8d are not included in the value calculation. Erythem due to staining is taken inot account.
all the particularities of the skin reaction were described
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
fully reversible within: 8 days
Remarks on result:
not determinable
Remarks:
Substance-related staining of the skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Reversibility:
fully reversible within: 8 days
Remarks on result:
not determinable
Remarks:
Substance-related staining of the skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
fully reversible within: 8 days
Remarks on result:
not determinable
Remarks:
Substance-related staining of the skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The substance was tested following OECD 404. Under the experimental conditions it did not induce any irritating/corrosive properties on the skin.
Executive summary:

The substance was tested for irritation potential to the skin following OECD 404. The sample was applied to the right shaved side of white zealand rabbits (male) while the left side was used as control in a semi-occulsive way. One animal over 3 showed an averaged value of edema score (24h/48h/72h) equal to 1 that was fully reversible within the period of observation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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:
October 4, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippischen Versuchstierzucht
- Weight at study initiation: 2,4 kg
- Housing: animals were kept in individual cages
- Diet (e.g. ad libitum): ad libitum "mümmel z"
- Acclimation period: 7d.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity : 40% RH
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Vehicle:
water
Controls:
other: untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 100 µl bulk volume of the amorphous substance

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
The substance was injected into the conjunctival sac of the lower eyelid of the right eye. The lids were then gently held together for 1 sec.
Observation period (in vivo):
From 1 hour to 8 days.
Number of animals or in vitro replicates:
3
Details on study design:
- The eye findings were 1 h, then 24, 48 and 72 h and 8 d after exposure.

TOOL USED TO ASSESS SCORE: The corneal findings was after the 24-hour observation with the fluorine-esceintest hedged (instillation of 1 drop of fluorescein solution in ophthalmic preparation directly on the cornea). The assessment was performed using an ophthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
other: not appliccale
Remarks on result:
not determinable
Remarks:
substance-related staining of the conjunctival
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
3
Reversibility:
fully reversible
The eye findings were 1 h, then 24, 48 and 72 h and collected 8 d after exposure. Evaluated pathological findings in the cornea (after turbidity degree and area) were, iris and conjunctiva (for redness, swelling and discharge).The degrees of damage after 24, 48 and 72 h on (1) cornea (O - 80), (2) iris (O - 10) and (3) the conjunctiva (O - 20), together O - 110 applied on 3 experimental animals.
Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for eye irritation following OECD 405. Under the experimental conditions it did not show any irritation potential to the eye.
Executive summary:

The substance was tested following OECD 405 for eye irritation. Three New Zeland rabbits were injected with the sample in water and checked regularly. None of the animals showed a score (chemosis, redness and discharge of the conjunctiva, iris and corneal opacity) higher than 1 and the effects were fully reversible within the period of observation.

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

Additional information

No eye irritant following OECD 405 (Dystar, 1981) rabbits, single instillation, observations at 1, 24, 48 and 72h

No skin irritant following OECD 404 (Dystar 1981) rabbits, semiocclusive, 4h exposure, observations at 1, 24, 48 and 72h.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

 

Skin irritant Cat 2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; o

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

 

Eye irritant Cat 2:

at least in 2 of 3 tested animals, a positive response of:

1)     corneal opacity ≥ 1 and/or

2)     2) iritis ≥ 1, and/or

3)      conjunctival redness ≥ 2 and/or

4)      conjunctival oedema (chemosis) ≥ 2

5)     calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

 

Based on the results of the in-vivo tests the substance is not classified as skin and eye irritant.