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Diss Factsheets

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
Study period:
From 08 March1988 to 15 March 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
3 white male New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion conditions on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chlorotoluene
EC Number:
202-424-3
EC Name:
2-chlorotoluene
Cas Number:
95-49-8
Molecular formula:
C7H7Cl
IUPAC Name:
1-chloro-2-methylbenzene
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: individually
- Diet: Standard diet ("ssniff K4") 100-120 g/animal and day
- Water: tap water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2 °C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² at the flank
- Type of wrap if used: Substance applied on a Hansamed - Wundpflaster
Hypoallergen (Beiersdorf No. 2342) and fixed with Fixomull-Stretch Klebevlies, (Beiersdorf No. 2039)

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

OBSERVATION TIME POINTS
1, 24, 48, 72 h and after 7 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.9
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point

Any other information on results incl. tables

For details on results see Illustration.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The irritant/ corrosive effects of the test substance o-chlorotoluene were tested on the skin of male rabbits in accordance with the OECD Guideline No. 404. The test substance was applied semiocclusively to the flank of three animals for 4 h. After 1, 24, 48 and 72 h and after 7 days scoring according to Draize was performed. Mean erythema score for 24/48/72 h was 0.9, mean oedema score was 0 over the same time period. The effect was fully reversible within 7 days.
Executive summary:

The irritant/ corrosive effects of the test substance o-chlorotoluene were tested on the skin of male rabbits in accordance with the OECD Guideline No. 404. The test substance was applied semiocclusively to the flank of three animals for 4 h. After 1, 24, 48 and 72 h and after 7 days scoring according to Draize was performed. Mean erythema score for 24/48/72 h was 0.9, mean oedema score was 0 over the same time period. The effect was fully reversible within 7 days.


The substance was slightly irritating to the skin but no classification according to EU Regulation 1272/2008 (CLP) is warranted.