Registration Dossier

Administrative data

Description of key information

not eye irritant for rabbits

not skin irritant for rabbits

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: experimental study on similar substance
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Principles of method if other than guideline:
The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Russian breed
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: PEG 400
Controls:
other: the untreated skin is used as a control.
Amount / concentration applied:
The tested substance was applied to each side in quantities of 0.5 g. Before applications a 50% polyethylene glycol (PEG 400) trituration was made.
Duration of treatment / exposure:
24 h
Observation period:
up to 72 h
Number of animals:
six rabbits: 3 male and 3 female
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.

The results of the skin irritation test are summarized in Table 1.

Animal

No.

Sex

Skin Reaction

24 hrs after application

 72 hrs after application

intact

skin

scarified

skin

intact

skin

scarified

skin

1     m

Erythema

0

0

0

0

 

Edema

0

0

0

0

2    m

Erythema

0

0

0

0

 

Edema

0

0

0

0

3    m

Erythema

 

0

0

0

0

 

Edema

0

0

0

0

4    f

Erythema

0

0

0

0

 

Edema

0

0

0

0

5    f

Erythema

0

0

0

0

 

Edema

0

0

0

0

6    f

Erythema

0

0

0

0

 

Edema

0

0

0

0

The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 hours on the intact and slightly scarified skin. Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those v/ith scores above 6 are considered severe irritants.

The primary irritation index of the tested item was 0.

Interpretation of results:
GHS criteria not met
Conclusions:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.
Therefore the tested item is to be considered as non-irritant to the skin of rabbits.
Executive summary:

The primary irritation effect was assessed following the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin.

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:
other: experimental study on similar substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Principles of method if other than guideline:
The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
not specified
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
Himalayan breed (WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany) weighing 1.5 to 2 kgs.
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds.
Duration of treatment / exposure:
30 sec
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
six rabbits (3 male and 3 female)
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. 1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritant / corrosive response data:
The primary irritation index is 3.2 which corresponds to a minimal irritating effect.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The primary irritation index is 3.2 which corresponds to a minimal irritating effect. Rinsing the eyes following instillation was of little
but assessable effect.
Executive summary:

The primary irritation effect was assested following the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The tested item contains a certain amount of a component which is classified as irritant to eyes.

The result show minimal irritation on rabbit eye following the indicated guideline but the tested item is to be considered as non-irritant to eye based on CLP criteria, table 3.2.2.7.1.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Some studies are available both for skin and eye irritation based on the patch-test method described in "Appraisal of the safety of Chemicals in Food, Drugs and cosmetics of the US Association of Food and Drug Officials.

The results show:

- no eye irritation for observation at 1, 24, 48 and 72 h.

- no skin irritation for observation at 1, 24, 48 and 72 h.

The test item doesn't show any irritating effects and as a consequence it could be stated that is not corrosive.

Justification for classification or non-classification

No classification for skin irritation/corrosion is warranted under Regulation 1272/2008

No classification for eye irritation/corrosion is warranted under Regulation 1272/2008