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Diss Factsheets

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:
13.12.1995-04.02.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
These tests were conducted in 1995.

Test material

Constituent 1
Details on test material:
Name of test material (as cited in study report): Coagulant 122 (solid)
Substance type: Clear slightly viscous yellow liquid
Physical state: 80.4% solids
Batch number: 9435262-8489
Storage condition of test material: 4°C in the dark under nitrogen

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
15 healthy female nulliparous and non-pregnant albino guinea-pigs were in the weight range of 292 to 324 g on arrival and approximately four to seven weeks of age. All the guinea-pigs were acclimatised to the experimental environment for twelve days prior to allocation to the main study.
Animal room temperature was maintained at approximately 21°C and relative humidity at 30-70%. these environmental paramaters were recorded daily. Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12
hours of artificial light (0700-1900 hours in each 24 hours period.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection - 4.02% v/v in water

Topical application - 80.4% v/v in water.

Concentration of test material and vehicle used for each challenge:
Topically: 80.4% and 40.2% v/v in distilled water.
Challengeopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection - 4.02% v/v in water

Topical application - 80.4% v/v in water.

Concentration of test material and vehicle used for each challenge:
Topically: 80.4% and 40.2% v/v in distilled water.
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:
80.4 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40.2 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
80.4 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40.2 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10 %
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 %
No. with + reactions:
10
Total no. in group:
10

Any other information on results incl. tables

The sensitivity of the guinea-pig strain used is checked periodically ar HRC with hexyl cinnamic

aldehyde, a known sensitiser. The results of recent tests are presented in Appendix 3.

Maximum concentration not causing irritating effects in preliminary test: 80.4 %

Signs of irritation during induction:
Intradermal injections:  Necrosis was recorded at the sites receiving Freund's Complete Adjuvant in the test and control animals.

Slight irritation was seen in test animals at sites receiving Coagulant 122 (solid), 4.02% v/v in water

Topical application:

Slight erythema was observed in test animals following topical application with Coagulant 122 (solid), 80.4% v/v in distilled water and slight erythema was seen in control guinea-pigs.

Evidence of sensitisation of each challenge concentration: None

Other observations:

There were no dermal reactions seen in any of the test or control animals (only isolated incidence of localised dermalirritation and/or sloughing seen in two control and four test animals.

No signs of ill health or toxicity were recorded.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Coagulant 122 solid does not require labelling with H317: May cause an allergie skin reaction in accordance with the Regulation (EC) 1272/2008.
Executive summary:

A study was performed to assess the skin sensitisation potential of Coagulant 122 solid using the guinea-pig. The method followed was thar described in:

EEC Methods for the determination of toxicity, Annex of Directive 92/69|EEC (OJ No. L383A, 29.12.92), Part B, Method 8.6. Skin sensitisation.

MAGNUSSON, B. and KLIGMAN, A.M. (1970) Allergic Contact Dermatitis in the Guineapig: Idenrtfication of contact allergens, Thomas, c.c., springfield, Illinois, u.s.A.

Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:

Intradermal injection: 4.02% v/v in water for irrigation

Topical application: 80.4% v/v in distilled water

Challenge application: 80.4 and 40.2% v/v in distilled water

All concentrations are expressed in % vlv of solid content, based on a purity of 80.4% solids.

Ten test and five control guinea-pigs were used in this study.

In this study Coagulant 122 solid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.