Phenol, 2-methoxy-, reaction products with 2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane, hydrogenated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

(no data on starting date) 30-AUG 1976 (date of report)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted before GLP principles (1976). However, study performed according to basic scientific principles acceptable for assessment although some information is missing on test conditions and on test substance composition.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: performed according to standard acute method

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Santal synthétique
- Analytical purity: not specified
See confidential details on test material for more information

Test animals

Species:

rat

Strain:

other: CD (COBS)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Charles River, France
- Age at study initiation: no data
- Weight at study initiation: 180-230 g
- Fasting period before study: no data
- Housing: no data
- Food consumption: no data
- Water consumption: no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS:
- Temperature: no data
- Humidity: no data
- Air changes: no data
- Photoperiod: no data

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
The product is applied as such to a previously shaved skin area of the back area (6x6 cm); zonne treated is then covered for 24 hours by an occlusive dressing (+ aluminum foil tape) to avoid that animals lick.

REMOVAL OF TEST SUBSTANCE
After this period, the dressing is removed and the treated area is washed with warm soapy water and then dried.

TEST MATERIAL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

VEHICLE
- no vehicle
- product administered as such

Duration of exposure:

24 hours

Doses:

0, 10 mL/kg (corresponding to 0, 9000 mg/kg)

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> mortality and clinical signs: observation at least once daily up to the end of the 14-day observation period (day 15).
> body weights: Weighing animals daily to lethal doses
- Necropsy of survivors performed: yes (macroscopic examination of main thoracic and abdominal organs).

Statistics:

Statistical analysis for body weight gain according to Student's t test.

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 9 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at 10 mL/kg.

Clinical signs:

No clinical signs and no skin irritation were noted.

Body weight:

Only a slight body weight decrease (5 to 8%) has been observed compared to the control group 5 days after exposure (males and females) and 10 day after exposure (males only).

Gross pathology:

No abnormality was observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute dermal LD50 value of the test item was found to be > 9000 mg/kg bw in male and female CD rats. According to the UN GHS and CLP criteria, the substance is not classified for the acute dermal toxicity.

Executive summary:

CD rats (10 males + 10 females per dose) have been exposed by dermal route during 24 hours at 0 and 10 ml/kg of Rhodiantal IBCH. Type of dressing: occlusive. Observation period: 15 days.

Results: No mortality was observed at 10 mL/kg, no clinical signs and no skin irritation were noted. Only a slight body weight decrease (5 to 8%) has been observed compared to the control group 5 days after exposure (males and females) and 10 days after exposure (males only). No abnormality was observed at necropsy.

Under the conditions of this study, the acute dermal LD50 value of the test item was found to be > 10 mL/kg (corresponding to > 9000 mg/kg bw) in male and female CD rats. According to the UN GHS and CLP criteria, the substance is not classified for the acute dermal toxicity.