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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:
disregarded due to major methodological deficiencies
Study period:
February/March 1973
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Due to the extremely low concentration of test substance in the vehicle and the apparant lack of an adjuvant being used, this study cannot be considered as a reliable study to address the skin sensitisation endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The experimental procedure was that prescribed by The Food and Drug Administration of the U.S.A. in "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, "1959, p51.
Deviations:
not specified
GLP compliance:
no
Type of study:
Maurer optimisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino, type not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 1 part PEG to 7.3 parts water
Concentration / amount:
0.1% solution
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: 1 part PEG to 7.3 parts water
Concentration / amount:
0.1% solution
No. of animals per dose:
10
Details on study design:
Prior to each injection of the test sample, the hair from the inter-scapular region was close-clipped using electric clippers. The test material was injected intracutaneously into the clipped inter-scapular region of each guinea-pig. The first injection consisted of 0.05 ml, while the remaining nine were of 0.1 ml each. Ten sensitizing injections were given on alternative days during a three week period.
Challenge controls:
After an incubation period of two weeks, a final challenge dose of 0.05ml was injected.
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
A comparison was made between the reactions elicited by the challenge dose and the average of readings observed during the sensitizing period. If the value for the challenge reading was substantially higher, the substance under test was considered to have produced sensitization, the degree of sensitisation being proportional to the difference between the two values.

Results and discussion

Any other information on results incl. tables

From the first 10 induction exposures, the scores were as follows:

Diameter: Average = 0.6, Maximum = 1

Colour: Average = 0.75, Maximum = 2 (in one animal only at one time point; all other scores were 1or less)

Height: Average = 0.72, Maximum = 1

From the challenge exposure after 2 weeks incubation, no score greater than 1 was seen in any animal for either diameter, colour or height.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the conditions of the test, no evidence of sensitisation was observed in a screening test performed using the test substance on guinea pigs in a Maurer optimisation test.
Executive summary:

The sensitisation potential of dimethyltin dichloride was examined in a Maurer optimisation test using albino guinea pigs. The experimental procedure was that prescribed by The Food and Drug Administration of the U.S.A. in "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, "1959, p51.

The intradermal route was used for both the inital and challenge exposures. The test substance was dissolved in a 1 part PEG to 7.3 parts water at 0.1 % concentration.

No evidence of sensitisation was observed in a screening test performed using the test substance on guinea pigs in a Maurer optimisation test.