Reaction mass of 4,4'-isopropylidenediphenol and phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is comparable with OECD Guideline 402 with exceptable restrictions (partly limited documentation, e.g. no details about the test substance and concentration used; pretreatment of exposed skin [intact & abraded] not clearly stated; only 4 rabbits per dose; type of coverage and systemic clinical signs not reported). Phenol is a constituent of the reaction mass so that phenol hazard data are applied in the hazard assessment.

Data source

Reference

Reference Type:

publication

Title:

The benzenediols: catechol, resorcinol and hydroquinone - a review of the industrial toxicology and current industrial exposure limits

Author:

Flickinger CW

Year:

1976

Bibliographic source:

Am Ind Hyg Assoc J 37: 596-606

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Source: Fisher Scientific company, catalogue no. A-91
No further data

Test animals

Species:

rabbit

Strain:

other: albino, no further data

Sex:

male

Details on test animals or test system and environmental conditions:

No further data

Administration / exposure

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

Abraded skin and intact skin was in contact with the phenol preparation in water for a maximum period of 24 hours (no further data).

Duration of exposure:

max. 24 h

Doses:

see Table below

No. of animals per sex per dose:

4 males

Control animals:

other: yes, untreated animals for assessment of body weight gain in treatment groups

Details on study design:

The study was conducted according to the Federal Hazardous Substances Act (FHSA) as published in the Federal Register of August 12, 1961 pages 7333-7341, Part 191. 14 days post exposure observation period. Necropsy performed (at least) in survivors.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

850 mg/kg bw

95% CL:

600 - 1 200

Mortality:

See Table below. Animals in the 2 highest dose groups died the first day after application (other rabbits survived)

Clinical signs:

No data on systemic effects.
The aqueous solution of phenol produced necrosis of the skin in all of the exposed rabbits.

Body weight:

Significant decrease in survivors.

Gross pathology:

No internal gross lesions were observed upon autopsy of the sacrificed animals (no futher data).

Other findings:

No data

Any other information on results incl. tables

Phenol is a major component of the reaction mass and by its toxicity drives the hazard of the rection mass, so that phenol hazard data are applied in the hazard assessment.

Acute dermal toxicity in males rabbits

Dose in mg/kg bw	Mortality
250	0/4
500	0/4
1000	3/4
2000	4/4

Applicant's summary and conclusion

Conclusions:

The LD50 in male rabbits in an acute dermal toxicity study was 850 mg/kg bw (95% confidence limits: 600-1200 mg/kg bw).

Executive summary:

The study is comparable with OECD Guideline 402 with exceptable restrictions (partly limited documentation, e.g. no details about the test substance and concentration used; pretreatment of exposed skin [intact & abraded] not clearly stated; only 4 rabbits per dose; type of coverage and systemic clinical signs not reported).

Four male albino rabbits per dose level received dermal administration of phenol preparations in water for max. 24 h at doses of 250, 500, 1000, or 2000 mg/kg bw. The post exposure observation period was 14 days. Animals in the 2 highest dose groups died the first day after application. No death was reported at 250 and 500 mg/kg bw but body weight gain was decreased. The aqueous solution of phenol produced necrosis of the skin in all of the exposed rabbits. No internal gross lesions were observed upon autopsy of the sacrificed animals.

Conclusion: The LD50 in male rabbits in an acute dermal toxicity study was 850 mg/kg bw (95% confidence limits: 600-1200 mg/kg bw).