Registration Dossier
Registration Dossier
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EC number: 434-770-8 | CAS number: 55314-16-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: Guinea pig (Dunkin Hartley)
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
20% in propylene glycol for intradermal induction and 50% in
propylene glycol for dermal induction.
No signs of irritation were observed to the highest test
substance concentration epidermally tested. Therefore, the
test site of all animals was treated with 10% SDS
approximately 24 hours before the epidermal induction in the
main study, to provoke a mild inflammatory reaction.
Concentration of test material and vehicle used for each challenge:
50% in propylene glycol.
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
20% in propylene glycol for intradermal induction and 50% in
propylene glycol for dermal induction.
No signs of irritation were observed to the highest test
substance concentration epidermally tested. Therefore, the
test site of all animals was treated with 10% SDS
approximately 24 hours before the epidermal induction in the
main study, to provoke a mild inflammatory reaction.
Concentration of test material and vehicle used for each challenge:
50% in propylene glycol.
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
The skin effects caused by the intradermal injections and
epidermal exposure during the induction phase are given
below. Since a 50% concentration, selected in the
preliminary irritation study, could not be injected, a 20%
concentration was used instead.
The signs of necrosis seen in the control animals after the
intradermal injection with vehicle only were in consistency
with the results in the preliminary irritation study after
injection of propylene glycol.
The reactions noted in the experimental and control animals
after the epidermal induction exposure were considered to be
enhanced by the SDS treatment.
Evidence of sensitisation of each challenge concentration:
The skin reactions observed in response to a 50% test
substance concentration in ten (of the ten) experimental
animals in the challenge phase were considered indicative of
sensitisation, based on the absence of any response in the
control animals.
These results indicate a 100% sensitization rate.
Other observations:
Toxicity / Mortality
No mortality occurred and no symptoms of systemic toxicity
were observed in the animals of the main study.
Body Weights
Body weights and body weight gain of experimental animals
remained in the same range as controls over the study
period.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
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