4,4'-cyclohexylidenedi-o-cresol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (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:

4,4'-cyclohexylidenedi-o-cresol

EC Number:

219-110-7

EC Name:

4,4'-cyclohexylidenedi-o-cresol

Cas Number:

2362-14-3

Molecular formula:

C20-H24-O2

IUPAC Name:

4-[1-(4-hydroxy-3-methylphenyl)cyclohexyl]-2-methylphenol

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Dimethyl cyclohexyl bisphenol (DMBPC; CAS No. 2362-14-3)
- Synonyms: Dimethyl bisphenolcyclohexane; 4,4’-cyclohexylidene di-o-cresol; 1,1-Bis(4-hydroxy-3-ethyl)cyclohexane; Bis-OC-Z
- Appearance: fine white powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female (nulliparous and non-pregnant) New Zealand White rabbits were received from the supplier. The animals weighed 2.06 - 2.60 kg and were at least 12 weeks old and were individually housed upon arrival in stainless steel suspended cages with hardwood chip bedding. The animals were acclimated for at least 5 days prior to dosing. Water and feed were provided ad libitum. The temperature and humidity were maintained at 68 ± 5 °F and 30 - 70 %, respectively. Room lights were on a 12-hour light/dark cycle.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

The application site, not less than 10 % of the body surface, was prepared approximately 24 hours prior to dosing by clipping the skin of the trunk free of hair. DMBPC, as received from the Sponsor, was slightly moistened to form a paste and introduced under gauze patches (two single layers thick) and applied directly to the clipped skin of 10 animals. The animals were immobilised and the patches were secured in place by wrapping the entire trunk of the animal with an impervious bandage. Test sites were secured to prevent the animals from ingesting the test substance. After the completion of the 24-hour exposure period, the wrapping was removed and the skin was gently wiped to remove any test substance still remaining.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

Five animals/sex were dosed at 2000 mg/kg (limit test). The animals were observed frequently during the first day and then a careful clinical examination was made at least once a day through 14 days. The test site of each animal was also observed for signs of erythema and oedema after the exposure period according to the Draize Scale for Scoring Skin Reactions. Animals were weighed at Day 0 (prior to dose administration), Day 7 and Day 14. Changes in body weights were calculated and recorded. At the end of the study, all animals were sacrificed by an injectable barbiturate and a gross necropsy was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the duration of the study.

Clinical signs:

other: No clinical signs of toxicity were observed in any animals over the course of the study. All animals displayed normal skin reactions over the course of the study.

Gross pathology:

No unusual findings were found during necropsy for the animals euthanized at study termination.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria

Conclusions:

Under the conditions of this study, DMBPC was determined to have an acute dermal LD50 of greater than 2000 mg/kg.

Executive summary:

The potential of the test material to cause acute toxicity was investigated in accordance with the standardised guidelines OECD 402 and EPA OPPTS 870.1200 under GLP conditions using the standard acute method.

Five male and 5 female clipped New Zealand White rabbits were exposed to a 2000 mg/kg bw limit dose of the test material in an occlusive fashion for 24 hours. After the completion of the 24-hour exposure period, the wrapping was removed and the skin was gently wiped to remove any test substance still remaining.

The animals were observed frequently during the first day and then a careful clinical examination was made at least once a day through 14 days. The test site of each animal was also observed for signs of erythema and oedema after the exposure period according to the Draize Scale for Scoring Skin Reactions. Animals were weighed at Day 0 (prior to dose administration), Day 7 and Day 14. Changes in body weights were calculated and recorded. At the end of the study, all animals were sacrificed by an injectable barbiturate and a gross necropsy was performed.

All animals survived the duration of the study. No clinical signs of toxicity were observed in any animals. All animals displayed normal skin reactions and all animals gained weight over the course of the study. No unusual findings were found during necropsy for the animals that were euthanised at study termination.

Under the conditions of this study, DMBPC was determined to have an acute dermal LD50 of greater than 2000 mg/kg.