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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:
September 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
The study is well-documented by the publication and thus acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
guinea pig sensitization test
Principles of method if other than guideline:
The study was conducted similar to OECD Guideline 406.
GLP compliance:
not specified
Type of study:
other: adjuvant and patch test (APT)
Justification for non-LLNA method:
At the time the study was performed the guinea pig sensitization test was a standard test method for the skin sensitisation potential. Thus, the study is considered to be reliable.

Test material

Reference
Name:
Unnamed

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC Inc.
- Weight at study initiation: 380 to 500 g
- Housing: The animals were housed individually in a stainless-steel cage.
- Diet: ad libitum; pellet diet
- Water: ad libitum; sterilised water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod: 12 hours dark/light cycle

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
3 %
Challenge
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
0.01%, 0.03%, 0.1%, 0.3%, 1% and 3%
No. of animals per dose:
5 animals for sensitizing group, 5 animals for control group
Details on study design:
main study:
intradermal injection of 0.1 mL emulsified FCA on day 1
The test material was applied occlusively for 24 hours
Two further occlusive applications at days 2 and 3
Occlusive applications of the test material on day 9
Exposure period from day 1 to 3

challenge exposure:
0.01 mL aliquots of various concentrations of the test material in the vehicle were applied for challenge on day 21.
duration of challenge: 1 day
Observations were conducted at day 22 and 23
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Group:
test group
Dose level:
0.01 %
No. with + reactions:
2
Total no. in group:
5
Remarks on result:
other: The reactions are expressed as 40 % at a concentration of 0.01 %.
Key result
Group:
test group
Dose level:
0.03 %
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: The reactions are expressed as 100 % at a concentration of 0.03 %.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Cobalt sulphate was determined to be a skin sensitizer category 1 based on the test results.