4,4'-isopropylidenebis[2-allylphenol]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Date of acclimatization: 27 November 1985; Date of application: 3 December 1985 ; Date of completion: 17 December 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP methodology followed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-isopropylidenebis[2-allylphenol]

EC Number:

217-121-1

EC Name:

4,4'-isopropylidenebis[2-allylphenol]

Cas Number:

1745-89-7

Molecular formula:

C21H24O2

IUPAC Name:

4-{1-[4-hydroxy-3-(prop-2-en-1-yl)phenyl]propyl}-2-(prop-2-en-1-yl)phenol

Test material form:

other: viscous liquid

Details on test material:

- Identification: TK 11907
- Batch: Op. 1
- Generic name: XU 292 B
- Stability: Guaranteed by the sponsor, until October 1991
- Storage conditions: Room temperature
- Description: Viscous liquid
- Purity: Pilot sample
- Test article received: 19 November 1985

Test animals

Species:

rat

Strain:

other: Rat, Tif: RAIf(SPF), F3-hybrid of Ril 1/TIF x Ril 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

-RationaIe: The rat has been selected for this test as being a Standard species for the determination of an acute dermal LD50.
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Initial Body Weight Range: 203 - 242 g
- Initial Age: 7-8 weeks
- Tndividual Identification: By cage number
- Husbandry: The animals were kept under conventional laboratory conditions. They were caged individually in Macroion cages type 2 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin).
The animal room was air conditioned: temperature 22±3° C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Remarks:

Liquid substance, used undiluted.

Details on dermal exposure:

- Volume (ml/kg body weight) applied: 2
- Pretreatment: Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an
electric clipper.

- Application: The required amount of the test substance was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing, which was fastened around the trunk with an adhesive elastic bandage.After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the reaction of the skin was appraised repeatedly.

days

Duration of exposure:

One single dose, applied onto the skin of the back.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females (in total 10 rats)

Control animals:

other:

Details on study design:

- Duration of observation period following administration: 14 days
- Mortality: daily, a.m. and p.m. on working days, a.m. on weekends
- Signs and Symptoms: daily
- Body weight: on days 1, 7, and 14
- Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Statistics:

From the body weights, the group means and their Standard deviations were calculated.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests. Additionally, erythema reactions were observed from day 1 to day 8 after the application and edema reactions from day 4 to day 8 after the application. The

Other findings:

Autopsie: No deviations from normal morphology were found.

Any other information on results incl. tables

Signs and symptoms:

Observations

Exposure day: hours

Day of post-exposure period

Observation

1

2

3

5

1

2

3

4

5

6

7

8

9

10

11

12

13

>13

2000 mg/kg

Dyspnea

XX

XX

XX

XX

X

X

X

X

X

X

X

X

X

X

X

X

Ruffled fur

X

X

X

X

X

X

X

X

X

X

X

X

X

Body position ventral

X

X

X

X

X

Body position curved

X

X

X

X

Erythema

X

X

X

X

Edema

X

X

X

X

X

X=slight XX=moderate XXX=marked

Body weight and standard deviations:

	Males
dose mg/kg	Day 1	Day 7	Day 14
2000	211/5.5	256/8.5	305/12.1

	Females
Dose mg/kg	Day 1	Day 7	Day 14
2000	216/15.2	214/13.4	226/9.8

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Upon an acute dermal application and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated where possible) was determined for TK 11907.

Executive summary:

The study, project no. 851048, was conducted to determine the acute dermal toxicity of TK 11907 in albino rats.

All the work was done at the Sisseln facility (CH-4332 Stein/Switzerland).

This experiemnt was performed according to the OECD 405.

Upon an acute dermal application and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated where possible) was determined for TK 11907.

LD50 in male rats; > 2000 mg/kg bw.

LD50 in female rats: > 2000 mg/kg bw.

LD50 in rats of both sexes: > 2000 mg/kg bw.

Symptoms

Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests.

Additionally, erythema reactions were observed from day 1 to day 8 after the application and edema reactions from day 4 to day 8 after the application.

The animals recovered within 13 days.