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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

secondary source

Title:

Acute eye irritation/corrosion study of CALCOZINE ~ black CSP powder in New Zealand white rabbits

Author:

NTRL

Year:

1985

Bibliographic source:

NTIS/ OTS0539527

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

C.I. Basic Violet 1

IUPAC Name:

C.I. Basic Violet 1

Constituent 2

Reference substance name:

8004-87-3

EC Number:

616-846-4

Cas Number:

8004-87-3

Molecular formula:

C24H28ClN3

IUPAC Name:

8004-87-3

Test material form:

other: DYE

Details on test material:

- Name of test material (as cited in study report): C.I. Basic Violet 1
- Molecular formula: C24H28ClN3
- Molecular: 393.95 g/mol
- Substance type: Organic
-OTHER- The enclosed study provides information on a commercial mixture.The mixture contains 21 % of C.I. Basic Violet 1 in a commercial mixture of CALCOZINE black CSP powder.

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Results

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.

Applicant's summary and conclusion

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.