2,4-dimethyl-6-(1-methyl-pentadecyl)phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01.10. - 29.10.1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dimethyl-6-(1-methyl-pentadecyl)phenol

EC Number:

411-220-5

EC Name:

2,4-dimethyl-6-(1-methyl-pentadecyl)phenol

Cas Number:

134701-20-5

Molecular formula:

C24 H42 O

IUPAC Name:

2-(hexadecan-2-yl)-4,6-dimethylphenol

Details on test material:

- Physical properties: liquid
- Storage conditions: room temperature

Test animals

Species:

rat

Strain:

other: Tif:RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein, Switzerland
- Weight at study initiation: 217 to 248 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Macrolon cages type 3
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 01.10. to 17.10.1991

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: on the back of the animals
- % coverage: 10
- Type of wrap if used: a 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: 24 hrs

TEST MATERIAL
- Amount applied: 2 mL

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:
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 administration and on days 7 and 14

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred in this study.

Clinical signs:

other: Slight piloerection was observed in both, female and male animals. The animals recovered within 2 days.

Gross pathology:

At autopsy, no deviations from normal morphology were found.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The dermal LD50 value of the test article in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The acute dermal toxicity of the test substance was assessed in a toxicity study following OECD guideline 402 and in compliance with GLP. The test article was administered to five TIF:RAIf rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the observation period. No mortality occurred. Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days. At autopsy, no deviations from normal morphology were found. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.