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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
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HR 99/130785, CAS 119-36-8

Test animals

Species:
rabbit
Strain:
other: Albino Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Moellegaard Breeding & Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.2-2.4 kg
- Housing: individually in PPO cages with perforated floor.
- Diet (e.g. ad libitum): Altormin 2123 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 May 1999 To: 1 June 1999

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped
Vehicle:
other: unchanged and diluted with ethanol/diethyl phthalate 1:1
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml (total volume including vehicle when diluted)
- Concentration (if solution): 1, 5, 10, 25, 100%

VEHICLE
- Amount(s) applied (volume or weight with unit): see above
- Concentration (if solution): 0, 75, 90, 95, 99%
- Lot/batch no. (if required): no data
- Purity: no data
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm per test site
- % coverage: no data
- Type of wrap if used: Gothaplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): mild soap and lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Standard OECD 404 scoring method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
1.67
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: For undiluted test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
0.67
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: for undiluted test substance
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.2
Max. score:
0.67
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: for 25% solution of test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Reversibility:
other: no reactions
Remarks on result:
other: for 25% solution of test substance
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Reversibility:
other: no reactions
Remarks on result:
other: for 1, 5 or 10% solution of test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Reversibility:
other: no reactions
Remarks on result:
other: for 1, 5, 10% solution of test substance
Irritant / corrosive response data:
For the undiluted test substance, animals showed from very slight to well-defined erythema and/or oedema from the 1-hour to the 72-hour observations. At the 7-day observation all animals showed small white scales on the test site. these had resolved by the 14-day observation.
For the 25% solution, only very slight erythema was noted in one animal at the 24- and 48-hour observations.
No reactions were noted for the lower test concentrations.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
MeS was slightly irritating to rabbits but does not require classification according to the criteria of EU DSD or CLP.
Executive summary:

The primary skin irritation of HR 99/130785 (methyl salicylate) was investigated according to the method recommended in the OECD Guideline No. 404 and EEC Guideline B.4. Four female albino rabbits were exposed to the test article and the vehicle at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined at 1, 24, 48 and 72 hours, as well as 7 and 14 days after the termination of exposure. Slight to well-defined skin reactions were observed. The mean scores reported were: undiluted MeS: 1.3 for erythema and 0.6 for oedema; 25% solution: 0.2 for erythema and 0.0 for oedema. No reactions were reported for 1, 5 or 10% solutions. According to directive 93/21/EEC, the test substance should not be classified as irritating to the skin.