Zinc O,O,O',O'-tetrabutyl bis(phosphorodithioate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

This study was mandatory at the time of registration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 Mar - 13 Mar 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zinc O,O,O',O'-tetrabutyl bis(phosphorodithioate)

EC Number:

230-257-6

EC Name:

Zinc O,O,O',O'-tetrabutyl bis(phosphorodithioate)

Cas Number:

6990-43-8

Molecular formula:

C16H36O4P2S4Zn (neutral monomer)

IUPAC Name:

zinc bis(O,O-dibutyl dithiophosphate)

Details on test material:

- Name of test material (as cited in study report): Zn-di-n-butyl dithiophosphate
- Physical state: light yellow liquid
- Analytical purity: ca. 92 %
- Lot/batch No.: 106 92 78
- Expiration date of the lot/batch: June 1992
- Stability under test conditions: stable
- Storage condition of test material: no special storage conditions

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Zimmermann, Untergröningen/Aalen, Germany
- Weight at study initiation: 2733 and 2940 g (males), 2942 g (female)
- Housing: individually in wire grating cages (area 2450 cm², height 42 cm) without bedding
- Diet: Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P (Raiffeisen Kraftfutter Kehl), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

3 days
Reading time points: 1, 24, 48 and 72 h

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
- Area of exposure: within an area of 3 x 5 cm of shaved skin on the dorso-lumbar region
- Type of wrap if used: the treated skin was covered with gauze, held in place with an occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: male

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: male

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: female

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: male

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: male

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: female

Irritant / corrosive response data:

After removal of the occlusive bandage after a period of 4 h, the exposure area was washed and cleaned with water. In the following observation period, dermal irritations in form of well-defined erythema (1 h and 24 h after treatment) were observed. 48 h after treatment the erythema were graded to be very slight which disappeared within 72 hours. (see Table 1).

Other effects:

Mortality: none of the rabbits died during the experiment.
Toxicological symptoms: during the observation period of 3 days none of the animals showed toxicological signs.
Behaviour: the reaction of the animals treated was quiet and watchful. The behaviour pattern was normal.
Body weight: the body weight of all animals had a normal physiological growth.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

 

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	0	2	0	2	0
24 h	2	0	2	0	2	0
48 h	1	0	1	0	1	0
72 h	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	1.00	0.00	1.00	0.00	1.00	0.00
Mean value 24 + 48 + 72 h all animals	1.00	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified