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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, no restrictions, fully adequate for assessment.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-88-259
- Physical state: clear colourless liquid
- Analytical purity: no data. Assumed to be 100%.
- Lot/batch No.: I
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products Inc, Denver, Pennsylvania, USA
- Age at study initiation: approximately 13 weeks
- Weight at study initiation: 2-3 kg
- Housing: individual in suspended stainless steel cages.
- Diet (e.g. ad libitum): Purina Rabbit Chow HF (pellets) ad libitum
- Water (e.g. ad libitum): ad libitum via automatic system
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 65-70°F (approx 18-21°C)
- Humidity: 40-88%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 12 July 1988 To: 19 July 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
7
Details on study design:
TEST SITE
- Area of exposure: right dorsal side
- % coverage: no information
- Type of wrap if used: gauze patch held loosely in contact with the skin by means of a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed using distilled water and paper towels
- Time after start of exposure: 4 hours

SCORING SYSTEM: Observations were according to the Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: very slight to moderate to severe erythema in all 7 animals 24, 48 and 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: very slight oedema in 5 animals at 24 hours. Very slight to slight oedema in all 7 animals at 48 and 72 hours.
Irritant / corrosive response data:
The incidence and severity of irritation increased as the study progressed, and by 72 hours all animals exhibited erythema, ranging from very slight to severe, and slight oedema. On day 7, erythema ranged from well-defined to severe for all animals, and oedema ranged from very slight to slight for 5 animals. The mean score for erythema was 2.43 at 72 hours and on day 7. The inflammation persisted in all test animals at the end of the observation time (individual scores for erythema on day 7 were 2, 2, 2, 4, 2, 3, and 2).

Any other information on results incl. tables

Mean scores for skin irritation

45 min

24 h

48 h

72 h

7 days

Mean (24, 48, and 72h scores)

Erythema

0.14

1.14

1.86

2.43

2.43

1.81

Oedema

1.00

0.71

1.14

1.43

0.86

1.10

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Toluene is moderately skin irritating.
Executive summary:

The skin irritation potential of toluene was assessed in 7 rabbits according to EU method B4. 0.5 mL of neat toluene was applied under semi-occlusive dressings for 4 hour and irritation responses noted for up to 7 days.

Erythema was seen in all 7 animals from 24 hours and persisted in all animals on day 7. Oedema was seen in all 7 animals from 24 or 48 hours and was still present in 5 animals on day 7. A mean erythema score exceeding 2 was observed which persisted for more than 24 hours (from 72 hours to 7 days) and persisted in all test animals at the end of the observation time (individual scores for erythema on day 7 were 2, 2, 2, 4, 2, 3, and 2).

Toluene is considered to be irritating to rabbit skin and warrants classification Xi, R38 under Dir 67/548/EEC and Category 2, H315 under GHS/CLP.