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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Bis(2-ethylhexyl)zinkdithiophosphat [MAK Value Documentation in German language, 2004]
Author:
The MAK Collection for Occupational Health and Safety
Year:
2012
Bibliographic source:
Bis(2-ethylhexyl)zinkdithiophosphat [MAK Value Documentation in German language, 2004]. The MAK Collection for Occupational Health and Safety. 1–14. 2012.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
A Buehler test was carried out for chemical bis (2-ethylhexyl) zinc dithiophosphate (CAS No: 4259-15-8) was conducted in guinea pigs according to OECD Test Guideline 406.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Reference substance name:
zinc bis[O,O–bis(2–ethylhexyl)] bis(dithiophosphate))
Cas Number:
4259-15-8
Molecular formula:
C16H35O2PS2.1/2Zn
IUPAC Name:
zinc bis[O,O–bis(2–ethylhexyl)] bis(dithiophosphate))
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report):zinc bis[O,O–bis(2–ethylhexyl)] bis(dithiophosphate))
- Molecular formula:C16H35O2PS2.1/2Zn
- Molecular weight :772.487 g/mole
- Substance type:Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report): bis (2-ethylhexyl) zinc dithiophosphate
- Molecular formula: C16H35O2PS2.1/2Zn
- Molecular weight: 772.487 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: P(OC[C@@H](CCCC)CC)(OC[C@@H](CCCC)CC)(=S)[S-].P(OC[C@@H](CCCC)CC)(OC[C@@H](CCCC)CC)(=S)[S-].[Zn+2]
- InChI: 1S/2C16H35O2PS2.Zn/c2*1-5-9-11-15(7-3)13-17-19(20,21)18-14-16(8-4)12-10-6-2;/h2*15-16H,5-14H2,1-4H3,(H,20,21);/q;;+2/p-2

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
5% in mineral oil
Day(s)/duration:
3 weeks
Adequacy of induction:
other: the lowest irritating concentration
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
1% in mineral oil
Day(s)/duration:
No data available
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: no data
- Test groups: 20
- Control group: 20
- Site: no data
- Frequency of applications: once a week for three consecutive weeks
- Duration: 3 weeks
- Concentrations: 5% in mineral oil

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 weeks
- Exposure period: no data
- Test groups: 20
- Control group: 20
- Site: no data
- Concentrations: 1% in mineral oil
- Evaluation (hr after challenge): no data
Challenge controls:
The control group was tested only with mineral oil.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4- dinitrobenzene and α-hexyl cinnamic aldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
other: control group
Dose level:
1% in mineral oil
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
no skin sensitization was oberved
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
test chemical
Dose level:
1% in mineral oil
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
The treated guinea pigs showed a negative result (3/20 degree 1 reactions in comparison to 1/20 degree 1 reactions in the solvent control).
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
The treated guinea pigs showed a negative result (3/20 degree 1 reactions in comparison to 1/20 degree 1 reactions in the solvent control).

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The chemical bis (2-ethylhexyl) zinc dithiophosphate (CAS No: 4259-15-8) was considered to be not sensitizing to the skin of guinea pigs in a Buehler test.

Executive summary:

A Buehler test was carried out for chemical bis (2-ethylhexyl) zinc dithiophosphate (CAS No: 4259-15-8) was conducted in guinea pigs according to OECD Test Guideline 406.

 

Induction was carried out once a week for three consecutive weeks with 5% of the test substance in mineral oil, the lowest irritating concentration, provocation 2 weeks after the last application with 1 % in mineral oil, the highest non-irritating concentration. The control group was tested only with mineral oil. For comparison, historical positive controls were used with 1-chloro-2,4- dinitrobenzene and α-hexyl cinnamic aldehyde.

 

The treated guinea pigs showed a negative result (3/20 degree 1 reactions in comparison to 1/20 degree 1 reactions in the solvent control).

 

Hence the chemical bis (2-ethylhexyl) zinc dithiophosphate (CAS No: 4259-15-8) was considered to be not sensitizing to the skin of guinea pigs in a Buehler test.