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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:
20 April 1999 - 4 June 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline and GLP. The report is however very concise and does not contain full details on methods and results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
- only 3 control animals and 5 test group animals were used.
- the study followed OECD guideline but it is not mentioned if the challenge was done under occlusion or for how long.
- the report is however very concise and does not contain full details on methods and results.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In-vivo data from a non-LLNA method has already existed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name : Rhodiastab X7
Lot or Batch Number : 9801511
Date received : 9th April 1999
Description : White powder
Container : Clear glass bottle
Storage at RTC : Ambient conditions
RTC reference number: 3807
Purity: 95.0%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
Induction (injection): 0.5% in water and 0.5% in FCA emulsion
Induction (topical): 60% in petrolatum
Challenge: 60% in petrolatum
Challengeopen allclose all
Route:
other: the study followed OECD guideline but it is not mentioned if the challenge was done under occlusion or for how long.
Vehicle:
petrolatum
Concentration / amount:
Induction (injection): 0.5% in water and 0.5% in FCA emulsion
Induction (topical): 60% in petrolatum
Challenge: 60% in petrolatum
No. of animals per dose:
control group: 3
test group: 5
Details on study design:
Animals were allocated to treatment to give a test group of 5 animals and a control group of 3 animals. In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites which had been pre-treated with sodium lauryl sulphate to promote an irritant reaction.
Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. The concentrations of the test substance used were determined by preliminary screening tests.
No further data.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
60%
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
60%
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
60%
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60%. No with. + reactions: 5.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
60%
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60%. No with. + reactions: 5.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The results indicate that the test substance may elicit a sensitisation response in the guinea pig, there being a 100% incidence of response at challenge following a period of induction exposure to the substance
Executive summary:

The study was performed according to OECD guideline and GLP. The results indicate that the test substance may elicit a sensitisation response in the guinea pig, there being a 100% incidence of response at challenge following a period of induction exposure to the substance.