Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP status unclear, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the test method for skin irritation as prescribed by OECD and EEC
Author:
Jacobs G and Martens M
Year:
1987
Bibliographic source:
J Toxicol Cutaneous Ocul Toxicol V6 pp215-226

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Mesitylene was applied to shaved rabbit skin and erythema and oedema recorded (using Draize criteria) at 1, 24, 48, and 72 hr after removal of the patch. Observations continued thereafter every 2 days until dermal responses had resolved in at least one rabbit.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): mesitylene
- Lot/batch No.: M720-0
- Supplier: Janssen Chimica, Beerse, Belgium
- Purity: no further details

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Proefstations voor Veeteelt (Merelbeke, Belgium)
- Age at study initiation: 9-24 weeks
- Weight at study initiation: 2.75-5.2 kg
- Housing: individual mesh wire bottom cages
- Conventional Laboratory diet ad libitum
- Tap-water ad libitum
- Acclimation period: At least 7 days
- Normal housing conditions

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: area of untreated skin used for comparison
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours, occluded
Observation period:
The animals were examined for signs of erythema and oedema formation at 1, 24, 48 and 72 hr after removal of the test patch
Number of animals:
5 or 6 (not specified)

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
other: mean for all animals, all timepoints
Time point:
other: overall mean for 24, 48 and 72 hr
Score:
2.33
Remarks on result:
other: time course information not available

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mesitylene caused erythema (overall mean 2.33) when applied to shaved rabbit skin under occlusion for 4 hr
Executive summary:

The skin irritation potential of mesitylene toward shaved rabbit skin was evaluated according to Annex V of directive 67/548 EEC. The sample (0.5 mL) was applied under occlusion for 4 hr with an area of untreated skin serving as control. The overall mean score for erythema (all animals over a 72 hour period) was 2.33; no oedema was reported. The results indicate that mesitylene is irritating to rabbit skin.