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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
26.08.85-23.09.85
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance tetramethylthiuram disulfide (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance. (For detailed information on the justification of read-across, please refer to the analogue justification document attached in IUCLID section 13).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
yes
Remarks:
The concentration used for induction did not produce a skin irritation. No positive controls.
GLP compliance:
yes
Type of study:
split adjuvant 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

Constituent 1
Chemical structure
Reference substance name:
Thiram
EC Number:
205-286-2
EC Name:
Thiram
Cas Number:
137-26-8
Molecular formula:
C6H12N2S4
IUPAC Name:
tetramethylthiuram disulfide
Details on test material:
- Name of test material (as cited in study report): Thiram technical
- Analytical purity: 99.4 %
- Impurities (identity and concentrations): Tetramethylthiuram monosulfide < 0.03 %, water 0.2 %, sodiumsulfate 0.2 %, zinc 0.0124 %
- Lot/batch No.: S94/06-85
- Specific gravity: ~ 0.3 g/cm3
- Melting point: 140 °C
- pH: 6.75 (suspension in 5 % water)
- Storage: at ambient temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
25 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
25 %
No. of animals per dose:
20 (test group), 10 controls

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
red spots and moderate and diffuse skin reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: red spots and moderate and diffuse skin reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
red spots and moderate and diffuse skin reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: red spots and moderate and diffuse skin reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: no information available
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
The test revealed a positive result, thus, the animals were sensitive towards sensitisation and the test is considered sufficiently valid for classification.

Any other information on results incl. tables

No skin reactions were observed after application of 25% (w/w) test substance in petrolatum, when applied to the shaved flanks of 4 animals for 24 hours under the same occlusive dressing to be used in the challenge reaction.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information