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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, 3 % in acetone does not irritate the skin. 10 % was the lowest irritant concentration after a single application of the test substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
The study was conducted in 1978.
Reliability:
4 (not assignable)
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 2 cm2 of clipped skin on the flank of a guinea pig. Skin reactions were noted at 24 hours.
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
guinea pig
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
other: Acetone
Controls:
no
Amount / concentration applied:
0.025 mL at concentrations of 3, 10, 30 and 100 %
Duration of treatment / exposure:
24 hours
Observation period:
24 hours
Number of animals:
No data
Details on study design:
A single application of 0.025 mL of each test concentration was simultaneously performed on an 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 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 not causing macroscopic skin irritation in any of the animals.
Irritation parameter:
other: Lowest irritant concentration
Basis:
other: No data
Time point:
other: 24 h
Score:
10
Reversibility:
no data
Irritation parameter:
other: Highest non-irritant concentration
Basis:
other: No data
Time point:
other: 24 h
Score:
3
Reversibility:
no data

Skin irritation after a single application

Solvent

Lowest irritant concentration

Highest non-irritant concentration

Acetone

10 %

3 %
Interpretation of results:
GHS criteria not met
Conclusions:
After a single application of the test substance, a 3% concentration in acetone does not cause skin irritation. Application of 10 % in acetone caused irritation.
After 7 days continuous application of the test item, only mild irritation was observed.
Executive summary:

The skin irritation potential of the test substance was assessed in guinea pigs.

After a single application of the test substance a 3% concentration in acetone did not irritate the skin.

A 10 % concentration was the lowest irritant concentration after a single application of the test substance.

This non-classification is based on the additional information after 21 days repeated dosing at 3%, 10%, 30% and 100% where after 7 days dosing at 100%, only slight irritation was observed.

Therefore after a single dose, it is extremely unlikely that oxyoctaline formate would be an irritant after 7 days and therefore would not be classifiable.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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, 3 % in acetone does not irritate the skin. 10 % was the lowest irritant concentration after a single application of the test substance.

Repeated applications of the test substance at 100 % resulted in irritation.


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

Effects on skin irritation/corrosion: 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. Irritation was observed at a 10 % concentration and therefore higher concentrations are likely to also produce irritation scores. The test substance is therefore classified as a Category 2 skin irritant.