4-(1,1,3,3-tetramethylbutyl)phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP, identification of test substance does not allow to differenciate whether it was the straight-chain or branched-chain form of octanol. This is however considered irrelevant for this endpoint.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

yes (only 7 days observation, 2 dose levels only, 3 animals per sex and dose only)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-octylphenol

EC Number:

217-302-5

EC Name:

p-octylphenol

Cas Number:

1806-26-4

IUPAC Name:

4-octylphenol

Constituent 2

Reference substance name:

79/298

IUPAC Name:

79/298

Details on test material:

Identified by trade name and by a structural formula (alkylchain only indicated as C8H17 which might be either straight-chain or branched).
purity: ca. 95 %

Test animals

Species:

rabbit

Strain:

Vienna White

Sex:

male/female

Details on test animals or test system and environmental conditions:

males: 2,9 kg
females: 3,1 kg
Ssniff K, Standard diet ad libitum

Shaving was done prior to application to back and flank, approximately 230 cm2

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The substance was administrated on skin. Thereafter, skin was covered with an inert foil for 24h. After exposure, skin was rinsed with water or a 1:1 mixture of water and polyethylenglykol 400

Duration of exposure:

24h

Doses:

1000 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

post-observation for 7 days

Results and discussion

Effect levels

Effect levels 1

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Remarks on result:

other: skin irritation, no necropsy findings

Mortality:

none

Clinical signs:

other: There were observations of a transition towards leather-like necrosis and persistent oedema after 24h as well as apathy and tremor. After 7 days, formation of scabs was observed and animals felt well.

Gross pathology:

no findings

Other findings:

no findings

Applicant's summary and conclusion

Interpretation of results:

other: not toxic, but highly irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD 50 to rabbits of substance 79/298 was found to be greater than 2000 mg / kg bw. The substance is not toxic and not corrosive. But due to skin irritation observed in 2 studies substance 79/298 has to be classified as irritant (Xi, R38).

Executive summary:

The acute dermal LD50 of substance 79/298 in rabbits of both sexes observed over a period of 7 days was found to be greater than 2000 mg/kg bw. No mortalities were observed, gross pathology was without findings. Observation revealed no signs of systemic effects, no full thickness destruction of skin tissue but skin irritation. Substance 79/298 causes erythema, oedema and necrotic skin alterations. However, sqamation and formation of scabs was observed, suggesting recovery of skin alterations. Especially the dermal irritation study described development of intact skin under removed scabs.