3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (GLP; test substance applied on a gauze patch of 12-16 instead of approx. 6 cm2)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981; because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.

Deviations:

yes

Remarks:

test substance applied on a gauze patch of 12-16 instead of approx. 6 cm2

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

EC Number:

407-920-5

EC Name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

Cas Number:

6390-69-8

Molecular formula:

C28 H42 O2

IUPAC Name:

3,3',5,5'-tetra-tert-butyl-[1,1'-biphenyl]-2,2'-diol

Details on test material:

- Name of test material (as cited in study report): generic name CA 16-178
- Physical state: solid, powder
- Analytical purity: 97.7% (not specified in the study [Lab. sample], transfered from 28d study [BASF SE [Ciba-Geigy Ltd/884619]], with same Lot/batch)
- Lot/batch No.: A 88103 / Z 1572R
- Storage condition of test material: room temperature
- Other: gloves and face masks as safety precautions

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2070 - 2150 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): standard rabbit pellet - Nafag No. 814, Gossau, Switzerland; ad libitum
- Water (e.g. ad libitum): fresh water; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: gauze patches were moistened before application with distilled water

Controls:

other: untreated skin site of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation).

Number of animals:

3 (all females)

Details on study design:

TEST SITE
- Area of exposure: an area of at least 36 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment
- % coverage: a gauze patch (approx. 12-16 cm2) bearing the test article was applied to the flank
- Type of wrap if used: the patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: 4 hours

SCORING SYSTEM: the skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Because no skin reactions were observed (neither erythema nor edema), it can be concluded that the test substance has no skin irritation potency in albino rabbits.

Other effects:

No other effects observed; no adverse effects on body weight gain (Table 1)

Any other information on results incl. tables

Table 1: Body weight (g)

Animal	First animals	Second animal	Third animal
Body weight at start of the test	2080	2150	2070
Body weight after 3 days (end)	2080	2200	2120

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information