Registration Dossier

Administrative data

Description of key information

Skin irritation
The skin irritation potential of the test substance was assessed in guinea pigs. After a single application of the test substance, 10 % in ethanol does not irritate the skin. 30 % was the lowest irritant concentration after a single application of the test substance.
Eye irritation
Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.

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:
The study was conducted in 1979.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.
Qualifier:
no guideline followed
Principles of method if other than guideline:
A single application of the test material was added to a 2 cm2 of clipped skin on the flank of a guinea pig. Skin reactions were noted at 24 h.
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
guinea pig
Strain:
not specified
Details on test animals and environmental conditions:
No data
Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
other: Ethanol
Controls:
no
Amount / concentration applied:
0.025 mL at concentrations of 1, 3, 10, 30 and 100 % for a single application and for continous application for 21 days as part of the skin sensitisation test.
Duration of treatment / exposure:
24 hours single aplication.
21 days for contineous application.
Observation period:
24 hours single aplication.
21 days for contineous application.
Number of animals:
No data
Details on study design:
A single application of 0.025 mL of each test concentration was simultaneously performed on one of the area measuring 2 cm2 of the flank of skin previously clipped and marked with a circular stamp.
The skin reactions were read 24 hours after the application of the test material. The minimum and maximum non-irritant concentrations were determined by an all-or-none criterion. The minimal irritant concentration was defined as the lowest one causing skin irritation. The maximal non-irritant concentration was defined as the highest one nont causing macroscopic skin irritations in any of the animals.
For the sensitisation determined by the OET on guinea pigs, the test substance was applied contineously for 21 days.
Irritation parameter:
other: Lowest irritant concentration
Basis:
other: No data
Time point:
other: 24 h
Score:
30
Reversibility:
no data
Irritation parameter:
other: Highest non-irritant concentration
Basis:
other: No data
Time point:
other: 24 h
Score:
10
Reversibility:
no data
Other effects:
After repeated applications over 21 successive days, slight skin irritation was observed at 7 days with a test concentration of 100 %. By 14 days this had increased to strong irritation. By 21 days slight irritation was observed although the first application site was changed because of strong skin irritation after 2 weeks of treatment.
At 30 % concentration, very slight irritation was observed at 7 and 14 days with moderate irritation observed at 21 days.
At 10 % concentration, no irritation was observed at 7 days; very slight irritation was observed at 14 and 21 days,
At 3 % concentration, no irritation was observed at 7, 14 or 21 days.

Skin irriation after a single application

Solvent

Lowest irritant concentration

Highest non-irritant concentration

Ethanol

30 %

10 %

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
After a single application of the test substance, 10 % in ethanol does not irritate the skin.
Repeated application of the test substance at 100 % indicated irritation after 21 days. However, after 7 days of repeated treatment only very slight irritiation was observed at 100%.
Executive summary:

The skin irritation potential of the test substance was assessed in guinea pigs. After a single application of the test substance, 10 % in ethanol does not irritate the skin. 30 % was the lowest concentration which gave very slight irritation after a single application of the test substance. In addition, after 14 days continuous application at 30%, only very slight irritation was observed. The test substance at 100% (neat) after 7 days continuous application gave rise to only very slight irritation. Therefore under the current CLP guidance, no classification is required.

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:
The study was conducted in 1979.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single or repeated instillations of 0.1 mL of the test material were made in one or more test concentrations in one eye of three rabbits per concentration group. The untreated eye served as control. Observations of the eyes were made immediately and at 1, 24, 48 and 72 hours, and 7 and 14 days.
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
10, 30 and 100 % (0.1 mL)
Duration of treatment / exposure:
No data
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
Three animals per group
Details on study design:
Single or repeated instillations of 0.1 mL of the test material were made in one or more test concentrations in one eye of three rabbits per concentration group. The untreated eye served as control. Observations of the eyes were made immediately and at 1, 24, 48 and 72 hours, and 7 and 14 days.
Irritation parameter:
cornea opacity score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
cornea opacity score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
cornea opacity score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
iris score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
iris score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
iris score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
chemosis score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
chemosis score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
chemosis score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
other: Conjunctival redness Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
other: Conjunctival redness Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
other: Conjunctival redness Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Concentration tested: 100 %
Irritant / corrosive response data:
Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.
Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.
Executive summary:

Single or repeated instillations of 0.1 mL of the test material were made in one or more test concentrations in one eye of three rabbits per concentration group. The untreated eye served as control. Observations of the eyes were made immediately and at 1, 24, 48 and 72 hours, and 7 and 14 days.

Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritation potential of the test substance was assessed in guinea pigs. After a single application of the test substance, 10 % in ethanol does not irritate the skin. 30 % was the lowest irritant concentration after a single application of the test substance.

After a single application of the test substance, 10 % in ethanol does not irritate the skin. Repeated application of the test substance at 100 % for 7 days indicated very slight irritation only.

 

Eye Irritation

Single or repeated instillations of 0.1 mL of the test material were made in one or more test concentrations in one eye of three rabbits per concentration group. The untreated eye served as control. Observations of the eyes were made immediately and at 1, 24, 48 and 72 hours, and 7 and 14 days.

Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.


Justification for selection of skin irritation / corrosion endpoint:
The study was conducted on the target substance in vivo in an appropriate test species.

Justification for selection of eye irritation endpoint:
The study was conducted on the target substance in vivo in an appropriate test species.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Skin irritation

Skin corrosion is defined as the production of irreversible damage to the skin following application of the test substance. Skin irritation is the production of reversible damage to the skin following application of the test substance. Substances can be allocated to one of two categories based on corrosive effects on the skin (Category 1) and irritation to the skin (Category 2) according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

Animal irritant responses within a test can be quite variable. The criterion for classification as a skin irritant accommodates cases where there is a significant irritant response but less than the mean score criterion for a positive test. In this study single doses of the test substance were administered at low concentrations but were not graded in a manner which allows mean values for erythema or oedema to be calculated. Only very slight irritation was observed after repeated application at 100% for 7 days. Therefore, no classificaton is warrented.

Eye Irritation

Serious eye damage means the production of tissue damage in the eye, or serious physical decay if vision following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

Eye irritation means the production of changes in the eye following application of the test substance to the anterior surface of the eye, which are fully reversible within 21 days.

Substances that have the potential to seriously damage the eyes are classified as Category 1 (irreversible effects on the eye).

Substances that have the potential to induce reversible eye irritation are classified in Category2 (irritating to eyes). 

A substance is classified in category 2 when in the eye of an animal a substance produces at least in 2 of 3 animals tested a positive response of:

·        Corneal opacity ≥ 1 and / or

·        Iritis ≥1 and /or

·        Conjunctival redness ≥ 2 and /or

·        Conjunctival oedema (chemosis) ≥ 2

when calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material and which fully reverses within 21 days.

A positive response was noted for conjunctival redness which was graded as ≥ 2 in two of the three animals tested. The effects were fully reversible within 14 days and therefore the test substance is classified as a Category 2 eye irritant.