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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: It is a well conducted albeit complicated study performed at a respected laboratory. However the study report contains some inconsistencies/errors and does not include some key items of data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
This was a modified study which explored cross sensitisation between structurally related substances.
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-dithiodi(benzoic acid)
EC Number:
204-352-8
EC Name:
2,2'-dithiodi(benzoic acid)
Cas Number:
119-80-2
Molecular formula:
C14H10O4S2
IUPAC Name:
2-[(2-carboxyphenyl)disulfanyl]benzoic acid
Test material form:
other: Solid
Details on test material:
The test material had a purity of 96.6%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Alderley Park
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 1-3% DMF in maize oil (intradermal) and DMF (epicutaneous)
Concentration / amount:
Intradermal Induction: 1%
Epicutaneous Induction: 75%
Challenge: 75% and 15%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 1-3% DMF in maize oil (intradermal) and DMF (epicutaneous)
Concentration / amount:
Intradermal Induction: 1%
Epicutaneous Induction: 75%
Challenge: 75% and 15%
No. of animals per dose:
20 test animals and 8 control
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
Percentage control animals that responded was substracted from the percentage of test animals that responded and compared to scale 2 below.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test chemical
Dose level:
75%
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 75%. No with. + reactions: 19.0. Total no. in groups: 20.0.
Reading:
1st reading
Group:
negative control
Dose level:
0%
No. with + reactions:
6
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. Group: negative control. Dose level: 0%. No with. + reactions: 6.0. Total no. in groups: 8.0.
Reading:
1st reading
Group:
test chemical
Dose level:
15%
No. with + reactions:
16
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 15%. No with. + reactions: 16.0. Total no. in groups: 20.0.
Reading:
1st reading
Group:
negative control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. Group: negative control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 8.0.

Any other information on results incl. tables

A strong response was observed to the 15% dose solution. The response to the 75% suspension was difficult to interpret due to the high incidence of irritation in the control animals. However irrespective of incidence of response, the greater intensity of the skin reactions in the test group compared to the controls indicated an allergic rather than an irritation response in the test animals.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DTBA was a skin sensitiser under the conditions of this test.