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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 14 to 28 October 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: AFNOR NF T 03-333
Deviations:
yes
Remarks:
The following parameters were missing: the age of animals at study start, the temperature, humidity and air changes during acclimation period.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ugilec 101
- Physical state: colourless liquid
- Storage condition of test material: bottle in aluminium

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: GWEN MEUR, France
- Age at study initiation: not reported
- Weight at study initiation: 2.5 +/- 0.1 kg
- Fasting period before study: not reported
- Housing: individually in cage of 540 x 360 x 315 mm
- Diet (e.g. ad libitum): 150 g of commercial granules given daily
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 October To: 28 October 1981

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 225 cm2 (15 x 15 cm)
- % coverage: not reported
- Type of wrap if used: adhesive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze, then water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): 0.99 g/mL



VEHICLE: No
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:daily observation and weighing on Days 1, 4, 7, 11 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: dermal reactions
Statistics:
Student's t test

Results and discussion

Preliminary study:
No mortality was observed at any dose level.
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
No treatment related clinical signs were observed. Diarrhea have been observed in 3 test substance treated animals, but also in 3 control animals.
Body weight:
No treatment related change has been observed.
Gross pathology:
No treatment related effect was elicited.
Other findings:
- Other observations:
Cutaneous reactions: In all treated animals, an moderate erythema (score = 2) was noted 24 hours after treatment, with oedema slight or moderate (score: 1 to 3). Oedema was reversible but not erythema.
Dryness of the skin from day 3 and skin desquamation from day 7 were also noted in most of treated animals. Those later findings persisted up to the end of experiment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The possible acute dermal toxicity of benzyl toluenes was evaluated in New-Zealand albinos rabbits. Benzyl toluenes was administered as such under occlusive binders at the dose level of 2000 mg/kg in groups of 10 rabbits (5 males and 5 females). The mortality and general behavior of the animals were observed for a period of 14 days after the administration of the test substance. No mortality was observed at the dose-level of 2000 mg/kg. The general behavior and the bodyweight of the animals were not influenced by the treatment. Under these experimental conditions, the LD0 of benzyl toluenes administered by dermal route in the rabbits was higher than 2000 mg/kg.