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

Endpoint summary

Description of key information

Skin irritation:

Skin irritation study was carried out on mammals to determine the irritation potency of Basic Violet 1.Basic Violet 1 did not cause any dermal irritation.

Eye irritation:

Basic Violet 1 eye irritation test result for New Zealand white rabbits was observed. Basic Violet 1 was observed as severe irritating substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: data from peer reviewed journals

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To determine the skin irritation potential of Basic Violet 1

GLP compliance:

not specified

Species:

other: mammals

Details on test animals or test system and environmental conditions:

no data

Type of coverage:

other: no data

Preparation of test site:

other: no data

Amount / concentration applied:

no data

Duration of treatment / exposure:

no data

Observation period:

no data

Irritation parameter:

overall irritation score

Basis:

mean

Remarks on result:

other: no signs of irritation observed

Interpretation of results:

not irritating

Conclusions:

Skin irritation study was carried out on mammals to determine the irritation potency of Basic Violet 1.
Basic Violet 1 did not cause any dermal irritation.

Executive summary:

Skin irritation study was carried out on mammals to determine the irritation potency of Basic Violet 1.Basic Violet 1 did not cause any dermal irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Qualifier:

according to guideline

Guideline:

other: OECD guideline

Principles of method if other than guideline:

To evaluate the potential for ocular irritation of the test article C.I. Basic Violet 1 when administered to New Zealand white rabbits.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Sgarlat"s Rabbitry, Harveys Lake
- Age at study initiation: Adult
- Weight at study initiation: 2.28 -2.77 kg
- Fasting period before study: No data available.
- Housing: The rabbits were individually housed in wire mesh bottom cages.
- Diet (e.g. ad libitum): NIH 09 Rabbit Ration (Zeigler Brothers, Gardners, PA) ad libitum
- Water (e.g. ad libitum): water ad libitum.
- Acclimation period: 5 days

Or Test Tissue- Not applicable.
- Source:
- Type:
- Acclimation :
- Housing conditions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour dark /12 hrs light

Vehicle:

not specified

Controls:

other: the other eye serves as control.

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

1,24,48 and 4th day

Observation period (in vivo):

30 seconds

Number of animals or in vitro replicates:

9 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 rabbits' eyes were irrigated
with lukewarm tap water
- Time after start of exposure: 30-seconds after instillation for approximately one minute.

SCORING SYSTEM: Draize Scale for Scoring Ocular Lesions.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1,24,48 hours and 4day

Reversibility:

not reversible

Remarks on result:

other: Severe Irritation was observed before and after washing of eyes.

Interpretation of results:

other: Severe Irritation

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Basic Violet 1 eye irritation test result for New Zealand white rabbits was observed. Basic Violet 1 was observed as severe irritating substance.

Executive summary:

Eye irritation effect ofBasic Violet 1 was observed in NewZealand white rabbits. 9NewZealand white rabbits were taken for the test. An amount of 0.1 g of the test article was instilled into one eye of each rabbit and other eye served as control. The treated eyes of six animals remained unwashed and three rabbits' eyes were irrigated with lukewarm tap water 30-seconds after instillation for approximately one minute. The grade of ocular reaction for each animal recorded at 1, 24. 48 and 72 hours and at 4^thday post instillation using the Draize Scale for Scoring Ocular Lesions. In six rabbits Eyes were not irrigated after test article instillation. While in 3 rabbits Eyes were irrigated 30seconds after test article instillation. Severe irritations were observed in all 9 rabbit before and after washing of eyes. Therefore it can be concluded that the test substance Basic Violet 1 was observed to be severe irritating in New Zealand white rabbits. Hence this substance can be classified as eye irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Skin irritation test by (Catherine Diamanteet.al, 2009) with target was observed. Skin irritation study was carried out on mammals to determine the irritation potency of Basic Violet 1.Basic Violet 1 did not cause any dermal irritation.

In other study by (ACToR database,2011) with similar substance (91-66-7) was observed . In the skin irritation study in rabbit N,N-diethylaniline was reported as moderately irritating to the skin in rabbit. However, this was not considered sufficient for classifying N,N-diethyl aniline as a skin irritant.

In other study by (Schreiber, G,1982) with similar substance (91-66-7) was observed. In the skin irritation study in rabbit N,N-diethylaniline was reported as slightly irritating to the skin in rabbit. However, this was not considered sufficient for classifying N,N-diethylaniline as a skin irritant.

In other study by (Smyth, H.F., et al., 1962) with similar substance (121-69-7) was observed. Primary skin irritation was tested in five albino rabbits. 0.1 mL of undiluted N,N- dimethylaniline was applied to uncovered clipped skin. The resulting reaction scored a 3 with grade 2 indicating the least visible capillary injection and grade 6 indicating necrosis. However, this score was not sufficient enough for classification of N,N- dimethylaniline.

In other study by (IUCLID Dataset. European Chemicals Bureau, Feb. 2000.) With similar substance (121-69-7) was observed. The application of 100 mg of 0.6% N,N-dimethylaniline in petrolatum for 24 hours did not cause irritation in volunteers.

In an in vitro skin irritation test,the test article, Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides, was found to be incompatible with the test due to extreme MTT auto-reduction or coloration causing extreme variations in viability data that could not be corrected for. Thus, no data provided as the test article Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS No.- 83968-28-9) was deemed incompatible with the assay.

On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance can be considered as not irritating to the skin.

Eye irritation:

Eye irritation effect ofBasic Violet 1 was observed in NewZealand white rabbits. 9NewZealand white rabbits were taken for the test. An amount of 0.1 g of the test article was instilled into one eye of each rabbit and other eye served as control. The treated eyes of six animals remained unwashed and three rabbits' eyes were irrigated with lukewarm tap water 30-seconds after instillation for approximately one minute. The grade of ocular reaction for each animal recorded at 1, 24. 48 and 72 hours and at 4^thday post instillation using the Draize Scale for Scoring Ocular Lesions. In six rabbits Eyes were not irrigated after test article instillation. While in 3 rabbits Eyes were irrigated 30seconds after test article instillation. Severe irritations were observed in all 9 rabbit before and after washing of eyes. Therefore it can be concluded that the test substanceBasic Violet 1 was found to be severe irritating in NewZealand white rabbits. Hence test substanceis likely to cause eye damage.

 

In other study by (Smyth, H.F., et al., 1962) with similar substance (121-69-7) was assessed in rabbit. N, N-dimethylaniline was scored 5 (on a 10-grade ordinal series based on the resulting corneal necrosis) when instilled into rabbit eye, indicating a severe burn from the application of 0.005 ml solution. Hence test substanceis likely to cause eye damage.

 

In other study by (U.S.Environmental Protection Agency, 2001) with similar substance (121-69-7) was assessed in rabbit. N,N-dimethylaniline caused moderate eye irritation to rabbit when tested at a concentration of 20 mg for 24 hours by a Draize test.Hence test substanceis likely to cause eye damage.

In an in vitro eye irritation test,the test article, Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS No.- 83968-28-9), was found to be incompatible with the test due to extreme MTT auto-reduction or coloration causing extreme variations in viability data that could not be corrected for. Thus, no data provided as the test article Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS No.- 83968-28-9) was deemed incompatible with the assay.

On the basis of available information for the target and its read across substance and applying weight of evidence approach, the test substance islikely to cause eye damage.

Justification for selection of skin irritation / corrosion endpoint:

Skin irritation test by (Catherine Diamanteet.al, 2009) with target was observed. Skin irritation study was carried out on mammals to determine the irritation potency of Basic Violet 1.Basic Violet 1 did not cause any dermal irritation.

Justification for selection of eye irritation endpoint:

Eye irritation effect ofBasic Violet 1 was observed in NewZealand white rabbits. 9NewZealand white rabbits were taken for the test. An amount of 0.1 g of the test article was instilled into one eye of each rabbit and other eye served as control. The treated eyes of six animals remained unwashed and three rabbits' eyes were irrigated with lukewarm tap water 30-seconds after instillation for approximately one minute. The grade of ocular reaction for each animal recorded at 1, 24. 48 and 72 hours and at 4thday post instillation using the Draize Scale for Scoring Ocular Lesions. In six rabbits Eyes were not irrigated after test article instillation. While in 3 rabbits Eyes were irrigated 30seconds after test article instillation. Severe irritations were observed in all 9 rabbit before and after washing of eyes. Therefore it can be concluded that the test substanceBasic Violet 1 was found to be severe irritating in NewZealand white rabbits. Hence this substance can be classified as eye irritant.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The test substance Basic Violet 1 can be classified as non irritant to skin and irritant to eye.