3-(2,2-dimethyl-3-hydroxypropyl)toluene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-05-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(2,2-dimethyl-3-hydroxypropyl)toluene

EC Number:

403-140-4

EC Name:

3-(2,2-dimethyl-3-hydroxypropyl)toluene

Cas Number:

103694-68-4

Molecular formula:

C12H18O

IUPAC Name:

2,2-dimethyl-3-(3-methylphenyl)propan-1-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males: 1.94 - 2.25 kg; females: 1.86 - 2.25 kg
- Fasting period before study: not specified
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days at least

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 2 °C
- Humidity: 50 - 85 %
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- Type of wrap used: gauze pads, several wrappings of "Elastoplast" and "Stülpa"

REMOVAL OF TEST SUBSTANCE
- Washing: removal with wet disposable gauze
- Time after start of exposure: 24 h after administration

TEST MATERIAL
- Amount applied: 5 mL / kg bw
- Concentration: pure

Duration of exposure:

24 h

Doses:

5 mL / 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
- Frequency of observations and weighing: daily observations, weighing on day 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin alterations

Results and discussion

Preliminary study:

Two female rabbits were employed in a preliminary range finding study. The dosage of the single dermal administration was 5.0 mL/kg. This preliminary study showed no mortalities.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: corresponding to 4985 mg/kg bw

Mortality:

Male: 5 mL/kg bw (ca. 4985 mg/kg bw); Number of animals: 5; Number of deaths: 0
Female: 5 mL/kg bw (ca. 4985 mg/kg bw); Number of animals: 5; Number of deaths: 0

Clinical signs:

other: None

Gross pathology:

Necropsies performed on all animals at termination exhibited no gross pathological findings.

Other findings:

Skin alterations:
The test item induced in all animals on the treated areas obvious erythema and edema. The symptoms described were observed in the same increased intensity during the first two days p.a. From the third day p. a. the symptoms diminished and from the 7th day p.a. 9 of 10 treated animals were without specific findings on the treated areas. One animal showed during the entire observation period fissures on the treated areas.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the acute dermal LD50 of the test item in the rabbit was determined to be greater than 5 mL/kg bw, corresponding to 4985 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test item was investigated in two groups of 5 male and 5 female rabbits of the White New Zealand strain. Any signs of reaction were recorded during the 14-day observation period. On the treated areas the sample caused erythema and edemas. Post-dosing weight gains (2 week values) of all animals did not show essential differences. No mortalities were observed. Nothing abnormal was found in the animals necropsied on day 14. The determination of the dermal LD50 showed the following result:

24 h + 14 days

Male/female dermal LD50 > 5.0 mL/kg bw (corresponding to 4985 mg/kg bw)