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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:
19 October 1956 to 27 December 1956
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Intracutaneous injection of test material in physiological saline on alternate days to a total of ten injections in each of eight male guinea pigs.
GLP compliance:
no
Remarks:
Prior to introduction of GLP
Type of study:
not specified
Justification for non-LLNA method:
Adequate existing data that allow a conclusion on the sensitizing potential of the substance were available

Test material

Reference
Name:
Unnamed

In vivo test system

Test animals

Species:
guinea pig
Sex:
male
Details on test animals and environmental conditions:
Test animals Species: guinea pig
Strain: White
Sex: male
Details on test animals and environmental conditions
−Eight, normal, healthy, white male guinea pigs, each weighing 300 to 400 g, were used for the experiment.
−Animals were maintained on a regular diet of rabbit pellets supplemented with spinach and kale throughout the experiment.
−As much hair as possible was removed from the sides and back of each guinea pig with electric clippers.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
first induction 0.05 mL, thereafter 0.1 mL of a 0.1% suspension
Day(s)/duration:
10 days
Challenge
No.:
#1
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.05 mL of 0.1% suspension 14 days after the last induction
Day(s)/duration:
1
Details on study design:
Induction
Route: intradermal
Vehicle: physiological saline
Concentration / amount: 0.1 % suspension of test material

Challenge
Route: intradermal
Vehicle: physiological saline
Concentration / amount: 0.1 % suspension of test material

Procedure
−The test material was made up as a 0.1 % suspension in physiological saline and injected using a 0.25 mL syringe with a 0.5 inch 26 gauge needle.
−Injections were made every other day until a total of ten had taken place.
−The first injection was 0.05 mL while the remaining injections were all 0.1 mL.
−An area consisting of 3-4 cm2 was used for the site of the injection. However, the initial injection was given slightly below the sensitization area.
−Two weeks after the final injection, a test injection of 0.05 mL of a freshly prepared suspension was administered.
−Reaction readings were made 24 hours after the initial and final 0.05 mL injections.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Dose level:
0.05 mL of 0.1% suspension
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Twenty four hours after the initial injection, small raised areas were observed. These areas showed a slight increase in color when compared to the surrounding area and the swellings were approximately 4-5 mm in diameter and 3-4 mm in height.

Fourteen days after the last sensitizing injection was given, 0.05 mL of a new 0.1 % suspension showed no greater effects than did the initial injection.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced no sensitizing effects in the guinea pig.
Executive summary:

A mixture of the substance was prepared as a 0.1 % suspension in physiological saline and administered to eight male guinea pigs by intracutaneous injection (initial injection of 0.05 mL in physiological saline followed by injections of 0.1 mL to a total of ten).

Twenty four hours after the initial injection, small raised areas were observed. These areas showed a slight increase in colour when compared to the surrounding area and the swellings were approximately 4-5 mm in diameter and 3-4 mm in height.

Fourteen days after the last sensitising injection was given, 0.05 mL of a new 0.1 % suspension showed no greater effects than did the initial injection.

The test material produced no sensitising effects in the guinea pig.