Registration Dossier

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: Assessed after consultation with the relevant Authority. Data migrated from NONS (67/548/EEC notification) files provided by Authority contained insufficient information.

Data source

Reference
Reference Type:
other: Body responsible for the test.
Title:
Unnamed
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: U.S. EPA Pesticide Assessment Guidelines Subdivision F, Part 81-6
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hartley Dunkin Pirbright White
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Intradermal: paraffin oil. Epicutaneous: petrolatum.
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Primary induction (intradermal): 0.2% in paraffin oil
b) Secondary induction (topical): 1% in petrolatum (gauze)

Concentration of test material and vehicle used for each challenge:
0.005% in petrolatum (gauze).
Challengeopen allclose all
Route:
other: topical
Vehicle:
other: Intradermal: paraffin oil. Epicutaneous: petrolatum.
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Primary induction (intradermal): 0.2% in paraffin oil
b) Secondary induction (topical): 1% in petrolatum (gauze)

Concentration of test material and vehicle used for each challenge:
0.005% in petrolatum (gauze).
No. of animals per dose:
Number of animals in test group: 22
Number of animals in negative control group: 22
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.005%. No with. + reactions: 0.0. Total no. in groups: 22.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.005%. No with. + reactions: 0.0. Total no. in groups: 22.0.

Any other information on results incl. tables

Signs of irritation during induction:

During the first induction, the Draize score was lower for the groups that were injected with the vehicle without test substance than in the group injected with the test substance.

Evidence of sensitisation of each challenge concentration:

While the sensibilized animals did not exhibit a reaction during the challenge, a slight reaction was observed in the animals in the control group after 48 hours.

The reaction to the first challenge was read at 48 hrs only, while the reaction to the rechallenge was read at 24 hrs only. No additional information is available.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
According to Annex I of DSD (67/548/EC), the available data on 2,3-bis((mercaptoethyl)thio)-1-propanethiol are conclusive but not sufficient for
classification.
According to Annex VI of CLP (1272/2008/EC), the available data on 2,3-bis((mercaptoethyl)thio)-1-propanethiol are conclusive but not sufficient
for classification.