Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other: Given below

Principles of method if other than guideline:

To evaluate the skin sensitization potential of Basic Violet 1 in guinea pig by modified Buehler and Klecak method.

GLP compliance:

not specified

Type of study:

other: Modified Buehler and Klecak method

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data available.

Route:

epicutaneous, open

Vehicle:

propylene glycol

Concentration / amount:

induction concentration of 10%
challenge concentrations of 10.0%, 5.0%, and 2.5%

Route:

epicutaneous, open

Vehicle:

propylene glycol

Concentration / amount:

induction concentration of 10%
challenge concentrations of 10.0%, 5.0%, and 2.5%

No. of animals per dose:

10

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period: 24 and 48 hour
- Test groups: 10
- Control group: no data
- Site: the left flanks of ten albino guinea pigs were shaved
- Frequency of applications: three times weekly (Monday, Wednesday Friday) for three consecutive weeks.
- Duration: 3 weeks
- Concentrations:10%

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: Two week rest period
- Exposure period:
- Test groups: 10
- Control group:
- Site: right flank of each guinea pig was shaved
- Concentrations: 100%,50%, and 25%
- Evaluation (hr after challenge): 24 hour

Positive control substance(s):

yes

Remarks:

DNCB (2,4-dinitrochlorobenze)

Positive control results:

The positive DNCB (2,4-dinitrochlorobenze) control at the 0.5% induction /challenge concentration elicited positive response in all animals tested.

Reading:

other: The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction.

Hours after challenge:

24

Group:

test chemical

Dose level:

induction concentration of 10% challenge concentrations of 10.0%, 5.0%, and 2.5%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No sensitization.

Remarks on result:

other: see Remark

Remarks:

Reading: other: The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction.. . Hours after challenge: 24.0. Group: test group. Dose level: induction concentration of 10% challenge concentrations of 10.0%, 5.0%, and 2.5% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No sensitization..

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance Basic violet 1 was observed to be non -sensitizing in guinea pig by modified Buehler and Klecak method.

Executive summary:

Skin sensitization test for Basic violet 1 was conducted in guinea pig usingmodified Buehler and Klecak     method for open Epicutaneous testing.For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest  period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentration(100%,50%, and 25% of the induction concentration) Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.. No erythema/edema was observed after application of test material .The test result was observed to be negative for the test substance. Therefore the test substance was considered as not sensitizing to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization

Skin sensitization test for Basic violet 1 was conducted in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest  period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentration(100%,50%, and 25% of the induction concentration) Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.. No erythema/edema was observed after application of test material .The test result was observed to be negative for the test substance. Therefore the test substance was considered as not sensitizing to the skin.

In other supporting study by (Sziza, M. and Podhragyai, L., 1957) with similar substance (91-66-7) was assessed in guinea pig   . No sensitization was reported from the Induction exposure by dermal application of a 10 % solution of N,N-diethylaniline; and challenge exposure by dermal application of 1 or 2 % solutions of test substance. N,N-diethylaniline was Classified as non sensitizer.

 

On the basis of available information for the target and its read across substance, the test substance can be considered as not sensitising to the skin.

Migrated from Short description of key information:

Skin sensitization test for Basic violet 1 was conducted in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest  period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentration(100%,50%, and 25% of the induction concentration) Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.. No erythema/edema was observed after application of test material .The test result was observed to be negative for the test substance. Therefore the test substance was considered as not sensitizing to the skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

On the basis of available information for the target and, the test substance Basic violet 1 can be classified as not sensitising to the skin.