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Toxicological information

Skin irritation / corrosion

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Administrative data

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
The test item was applied once to the intact skin under semi-occlusive patches for 4 hours. After removal of the patches and wiping the treated areas the skin was examined for irritation. Further assessments were made 24, 48 and 72 hours after treatment.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-12 weeks

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

POSITIVE & NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL for solutions or 0.2 g for solids
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
8
Details on study design:
TEST SITE
- Area of exposure: 3 x 3 cm
- % coverage: 100%
- Type of wrap if used: canvas body sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: 8-point anchored ordinate scale ranging from 'a' (very slight) to 'h' (severe). At the end of the test the reaction grades are converted to numerical scores to calculate the total irritation score per site.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.83
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.04

Any other information on results incl. tables

Individual skin irritation scores

8-point anchored ordinate scale:

Rabbit N° 24 hours 48 hours 72 hours
erythema oedema erythema oedema erythema oedema
1 d e d d b c
2 c c c c a b
3 d c d d d c
4 d d d d d d
5 d d c c b c
6 c c d c b b
7 c e c d c d
8 d e d d c d

a very slight
b slight
c fairly distinct
d quite distinct
e becoming well developed
f well developed
g becoming severe
h severe

Numerical scores to calculate the total irritation score:

Rabbit N° 24 hours 48 hours 72 hours Average
erythema oedema erythema oedema erythema oedema erythema oedema
1 2 3 2 2 1 2 1,67 2,33
2 2 2 2 2 1 1 1,67 1,67
3 2 2 2 2 2 2 2,00 2,00
4 2 2 2 2 2 2 2,00 2,00
5 2 2 2 2 1 2 1,67 2,00
6 2 2 2 2 1 1 1,67 1,67
7 2 3 2 2 2 2 2,00 2,33
8 2 3 2 2 2 2 2,00 2,33
Average 1,83 2,04

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not skin irritant.
Executive summary:

In the current study the irritation effects of the test substance were investigated in rabbits. The study was not according to an OECD TG, however, it is similar to OECD 404.

The test item was applied undiluted to the clipped and intact skin under semi-occlusive patches for 4 hours. After removal of the patches and wiping the treated areas irritation reactions were examined immediately. Further assessments were made 24, 48 and 72 hours after treatment. Positive (Geranial and cyclamen aldehyde) and negative controls (diethyl phthalate) were tested in parallel.

The reaction grades for each treatment group were converted to corresponding numerical scores that were used to calculate the total irritation score per animal.

Under the conditions of this study, the undiluted test material produced a moderately irritating effect to rabbit skin, which was still visible after 72 hours treatment. The positive controls, geraniol and cyclamen aldehyde, produced reactions much more severe and the control diethyl phthalate showed no visible signs after 72 hours.

According to the classification criteria as stipulated in CLP, a classification as a skin irritant is required in case the mean erythema or oedema score over 24, 48 and 72 hours is at or above 2.3 in at least 2 out of 3 animals. The individual scores reported in this study indicates that all erythema scores are < 2.3. Out of 8 animals, 3 rabbits have an oedema score of 2.33. All other animals (5 out of 8) have an oedema score < 2.3. From these observations it can be concluded that the test item does not require classification as a skin irritant in accordance with the CLP regulation.