2,2'-methylenebis(6-nonyl-p-cresol)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 March 1957 - 27 December 1957

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study pre-dates GLP and the standard guidelines; nevertheless, data is well reported and the experiment is conducted in accordance with generally accepted scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The acute dermal toxicity of the test material was investigated by occlusive exposure for 24 hours.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-methylenebis(6-nonyl-p-cresol)

EC Number:

232-092-5

EC Name:

2,2'-methylenebis(6-nonyl-p-cresol)

Cas Number:

7786-17-6

Molecular formula:

C33H52O2

IUPAC Name:

2-[(2-hydroxy-5-methyl-3-nonylphenyl)methyl]-4-methyl-6-nonylphenol

Test material form:

liquid: viscous

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Adult.
- Housing: Animals were caged individually.
- Diet: ad libitum.
- Water: ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

- The rabbits were depilated over the entire trunk. Measured volumes of the test material were maintained in contact with the skin by means of a gauze bandage, over which a loose-fitting, impervious plastic sleeve was placed. The sleeve was constricted at both ends in order to prevent leakage of the test sample.
- At the end of the exposure period, the wrappings were removed and the skin wiped with absorbent cotton.

Duration of exposure:

24 hours

Doses:

Doses of 8 and 16 mL (7560 and 15120 mg, respectively) per kg bw.

No. of animals per sex per dose:

1 animal treated at the 8 mL dose level, 10 treated at the 16 mL dose level)

Control animals:

no

Details on study design:

- In a 14 day observation period, records were made of bodyweight, appearance and behaviour.

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 15 120 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen.

Clinical signs:

other: The appearance and behaviour of the animals was normal throughout. Some transient skin irritation was seen however this was completely reversible within 4 to 7 days.

Any other information on results incl. tables

Table 1 Net Gain in Bodyweight

Dose		Rabbit No.	Net Gain in Bodyweight (g)
g/kg	mL/kg
7.56	8.0	1	470
15.12	16.0	2 3 4 5 6 7 8 9 10 11	0 100 100 500 300 300 0 -200 100 700

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was found to be not systemically toxic to the rabbit at doses of 8 and 16 mL/kg bw (equivalent to 7560 and 15120 mg/kg bw, respectively). The LD50 was considered to be greater than the highest dose tested, 16 mL/kg bw (15120 mg/kg bw). Under the conditions of the study, there is no requirement for the material to be classified in accordance with EU criteria.

Executive summary:

The potential of the test material to cause toxicity via the dermal route was assessed in the albino rabbit.

The depilated trunk of 11 rabbits was exposed to large doses of the test material for a period of 24 hours in an occlusive fashion. A single rabbit was treated with a dose of 8 mL/kg bw; 10 rabbits were treated with a dose of 16 mL/kg bw. Exposure was followed by a 14 day observation period.

No signs of systemic toxicity were observed. Behaviour, appearance and bodyweights (with the exception of 1 animal) were completely normal throughout the study. Some transient skin irritation was observed however this was completely reversed within 4 to 7 days.

 

The test material was found to be not systemically toxic to the rabbit at doses of 8 and 16 mL/kg (equivalent to 7560 and 15120 mg/kg bw, respectively). The LD50 is considered to be greater than the highest dose tested, 16 mL/kg bw (15120 mg/kg bw). Under the conditions of the study, there is no requirement for the material to be classified in accordance with EU criteria.