Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 Dec 1981 - 14 Jan 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study. Restriction due to missing details in study report. Missing details did not affect ability to evaluate effect of test substance on skin sensitisation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)

EC Number:

224-235-5

EC Name:

Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)

Cas Number:

4259-15-8

Molecular formula:

Too complex

IUPAC Name:

1-Hexanol, 2-ethyl-, O,O-diester with phosphorodithioic acid, zinc salt

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: between 300 and 400 g
- Housing: the animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR part 3. Five guinea pigs per cage were housed in stainless steel cages with elevated wire mesh flooring.
- Diet: Charles River Guinea Pig Formula was provided ad libitum.
- Water: tap water was provided ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 2 °F
- Humidity (%): 45 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 December 1981 To: 14 January 1982

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

other: white mineral oil

Concentration / amount:

5.0 % w/v

Challenge

Route:

epicutaneous, occlusive

Vehicle:

other: white mineral oil

Concentration / amount:

5.0 % w/v

No. of animals per dose:

20 animals / dose

Details on study design:

RANGE FINDING TESTS: Unknown

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week following intradermal injection and 2 days (48 h) after dermal application.
- Test groups: 1 group of 20 male animals.
- Control group: Not included.
- Site: skin over the shoulders.
- Frequency of applications: For induction stage: intradermal injections were made once at 3 pairs of sites simultaneously, 7 days later followed by dermal application of test material. Then the animals were allowed to rest for 2 weeks.
- Duration: total of 3 week time period.

- Concentrations: 5% w/v

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 21 h
- Test groups: 1 group of 20 male animals.
- Control group: Not included.
- Site: skin over the shoulders.
- Concentrations: 5% w/v
- Evaluation (hr after challenge): 24 h and 48 h

Challenge controls:

Not included

Positive control substance(s):

not required

Results and discussion

Positive control results:

n/a

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5% w/v

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5% w/v

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

CLP: not classified

Executive summary:

In a Magnusson-Kligman Guinea Pig maximization test, 20 Dunkin-Hartley strain albino Guinea Pigs were treated with 5.0% w/v test substance, Scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the albino guinea pig.