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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
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable 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:
other: U.S. EPA Pesticide Assessment Guidelines Subdivision F, Part 81-6
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1993 and can be used as a surrogate for a LLNA.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
EC Number:
411-290-7
EC Name:
2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
Cas Number:
131538-00-6
Molecular formula:
C7 H16 S5
IUPAC Name:
2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
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:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
0.025 % dilution in vaseline
No. with + reactions:
22
Total no. in group:
22
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
0.025 % dilution in vaseline
No. with + reactions:
22
Total no. in group:
22
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
no indication of skin sensitisation

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:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
It was conluded that GST does not cause any primaty sensittization in guinea-pigs using the Magnusson-Kligman method.

However, the substance needs to be classified as potential skin sensitizer based on human experience in one production plant According to Annex VI of CLP (1272/2008/EC)