A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

92/69/EEC

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives

EC Number:

421-820-9

EC Name:

A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives

Cas Number:

192268-65-8

Molecular formula:

Unspecified

IUPAC Name:

O,O,O-triphenyl phosphorothioate; O-2,4-di-tert-butylphenyl O,O-diphenyl phosphorothioate; O-2-tert-butylphenyl O,O-diphenyl phosphorothioate; O-2-tert-butylphenyl O-4-tert-butylphenyl O-phenyl phosphorothioate; O-4-tert-butylphenyl O,O-diphenyl phosphorothioate

Details on test material:

- Appearance: yellowish liquid.
- Storage condition of test material: Room temperature in dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: Approximately 11 to 13 weeks of age.
- Weight at study initiation: 2.6 to 3.1 kg.
- Housing: housed individually in metal cages with perforated floors.
- Diet: ad libitum; standard laboratory diet SDS Stanrab (P) Rabbit Diet (not analysed for nutrients, contaminants or micro-organisms)
- Wate: ad libitum; (routinely analysed for contamination, usually weekly).
- Acclimation period: All rabbits were acclimatised to the experimental environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C.
- Humidity (%): 30 – 70%.
- Air changes (per hr): 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

4 days

Number of animals:

3

Details on study design:

TEST SITE
- Site of application: Dorso-lumbar region.
- Area of exposure: applied under a 25 mm x 25 mm gauze pad to intact skin on each animal.
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes; with warm water (30° to 40°C). The treated area was blotted dry with absorbent paper
- Time after start of exposure: 4 hours.

Clinical signs:
All animals were observed daily for signs of ill health or toxicity.

Dermal responses:
Examination of the treated skin was made on Day 1 (i.e., approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
SCORING SYSTEM:
Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading 4

Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.333

Max. score:

4

Reversibility:

fully reversible within: 24 h after exposure

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.667

Max. score:

4

Reversibility:

fully reversible within: 72 h after exposure

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.667

Max. score:

4

Reversibility:

fully reversible within: 48 h after exposure

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.333

Max. score:

4

Reversibility:

fully reversible within: 24 h after exposure

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.667

Max. score:

4

Reversibility:

fully reversible within: 48 h after exposure

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.667

Max. score:

4

Reversibility:

fully reversible within: 48 h after exposure

Irritant / corrosive response data:

Erythema score: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals).
Edema score: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals).
Reversibility of any observed effect: Changes fully reversible within 4 days.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met