Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
10 animals/group, low concentration during induction, no reliability check reported
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A klimisch 2 Buehler study already existed on the test substance. Therefore, it was considered scientifically unjustified to re-run the same study according to the LLNA method.

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
EC Number:
288-917-4
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
Cas Number:
85940-28-9
Molecular formula:
C23.H50.O4.S4.P2.Zn
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
Details on test material:
- Physical state: liquid
- Analytical purity: 100%
- Effective substances: solution of Zn-dialkyldithiophosphate (about 80%) in mineral oil (about 20%)
- Batch No.: 205 92 08
- Expiration date: May 1993
- Stability under test conditions: stable at dry storage

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna Süddeutsche Versuchstierfarm, Tuttlingen, Germany
- Age at study initiation: < 1 year
- Weight at study initiation: 262 - 365 g
- Acclimation period: 5 days

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
12.5 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
12.5 %
No. of animals per dose:
control group: 10 animals
treatment group: 10 animals
Details on study design:
RANGE FINDING TESTS: The skin reactions (irritation) after a single dermal exposure of the test substance were tested. Four groups of two animals each were tested with different concentrations of the test substance for a time of 72 h. Sesame oil was used as thinner. The test substance was not administered to the control animals. However, in all other items (clipping, putting the occlusive bandage on the guinea pigs for 6 h), the control animals were treated in the same way as the test animals.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: day 0, day 7 and day 14 epicutaneous for 6 h
- Test groups: 1 with 10 animals
- Control group: 1 with 10 animals
- Vehicle group: 1 with 6 animals
- Site: left flank
- Concentrations: 12.5 %


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28 (treatment group, control group), 27 (vehicle group)
- Exposure period: 6 h
- Test groups: 1 with 10 animals
- Control group: 1 with 10 animals
- Vehicle group: 1 with 6 animals
- Site: right flank
- Concentrations: 12.5 %
- Evaluation (h after challenge): 24 and 48 h after removal of the bandage
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.3 mL 12.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.3 mL 12.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.3 mL 12.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.3 mL 12.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.3 mL 12.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 mL 12.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3 mL 12.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 mL 12.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Erythemata, oedemata or other signs of allergic reactions of the animals could not be noted during the examination of effects to the challenge exposure.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not sensitising to skin. The test substance does not meet the criteria for EU or GHS-EU classification.