Registration Dossier

Diss Factsheets

Administrative data

Description of key information

rabbit, 24 h, semi-occlusive, 7 d observation, negative

rabbit, 50 mg instillation, 7 d observation, negative

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:
other: Proprietary study reported in summary only
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test method used 24-hour of semi-occlusive exposure of the interior surface of the ear of 2 rabbits.
GLP compliance:
no
Remarks:
study pre-dates GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: solitary
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg/animal
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
TEST SITE
- Type of wrap if used: bandage dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water and soap/plant oil
- Time after start of exposure: 24 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Results are not reported in detail, however the report states that the test material is not irritating to skin.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Although the irritation scores are not reported, it is concluded that the test material is not a skin irritant.
Executive summary:

500 mg of the test material was applied under semi-occlusive conditions to the interior surface of the ears of two New Zealand White rabbits. Residual test material was removed after 24 hours by washing with soap and water; animals were obsereved for 7 days. Scores for irritation are not reported, however it is stated in the report that the test material was not a skin irritant under the conditions of the study. The study protocol is not standard, however it can be concluded that the substance is not a skin irritant.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary study reported in summary form only
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study method is broadly comparable to OECD 405.
GLP compliance:
no
Remarks:
(the study pre-dates GLP)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: solitary
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
50 mg/animal
Duration of treatment / exposure:
Single exposure; no details on washing
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
no details provided
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
The scores for eye irritation are not reported, however it is stated that the test material was not found to be a primary eye irritant in this study.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to the rabbit eye under the conditions of this study
Executive summary:

50 mg of the test material was instilled into one eye of two New Zealand White rabbits; ocular reactions were observed for 7 days. Scores for eye irritation are not reported, however the test material was not irritating to the rabbit eye under the conditions of this study.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study of skin irritation was performed to a non-standard protocol. However the exposure method used in this study (24 -hour application to the interior surface of the rabbit ear) is noted to be more stringent than 4 h as specified under the current OECD guideline 404. The finding in this study that the test material is non-irritating to skin is therefore acceptable (Thyssen 1979).

Eye irritation

A study of eye irritation was performed in rabbits according to a protocol broadly comparable to the current OECD guideline 405. The test material was found to be non-irritating under the conditions of this study (Thyssen 1979).

Although the studies are not reported in great detail and are not performed in strict compliance with current guidelines, they indicate that the substance is not irritating to the skin or eyes. This conclusion is supported by the absence of findings of irritation in humans following occupational exposure. Further testing for skin and eye irritation is therefore not justified.

Justification for classification or non-classification

Based on the results of these studies and the absence of findings in occupationally exposed workers, no classification for skin or eye irritation is proposed according to Regulation (EC) No 1272/2008.