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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:
1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Due to the physical-chemical properties, the test substance had to be applied by weight.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
EC Number:
216-971-0
EC Name:
3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
Cas Number:
1709-70-2
Molecular formula:
C54H78O3
IUPAC Name:
3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
Details on test material:
- Physical state: solid, white
- Analytical purity: >9S%
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: young adult rats were used
- Weight at study initiation: 217 to 268 g
- Housing: individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France).
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned with lukewarm water
- Time after start of exposure: After 24 hours

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 g/kg bw (corresponding approximately to 4 ml).
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before application and on days 7 and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred in this study.
Clinical signs:
Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. The animals recovered within 2 days.
Gross pathology:
At necropsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
LD50 > 2000 mg/kg bw