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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute Toxicity Evaluation of Solvent Red 1
Author:
Gunda Reddy and Dale A. Mayhew
Year:
1996
Bibliographic source:
International Journal of Toxicology Vol 15, Issue 1_suppl, pp. S43 - S44, 1996
Reference Type:
secondary source
Title:
Dermal, Eye and Oral toxicological evaluations, phase IV report with Disperse Red 11, Disperse Blue 3, Solvent Red 1 and Red and Violet Mixtures.
Author:
U.S. Army Medical Bioengineering Research and development Laboratory
Year:
1986
Bibliographic source:
NTRL- April - 1986, Page no 1-169.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of Solvent Red 1 in New Zealand White rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material : 1-[(2-methoxyphenyl)diazenyl]-2-naphthol
- Common Name: Solvent Red 1
- Molecular formula : C17H14N2O2
- Molecular weight : 278.31 g/mol
- Smiles notation : c12c(\N=N\c3c(cccc3)OC)c(ccc1cccc2)O
- InChl : 1S/C17H14N2O2/c1-21-16-9-5-4-8-14(16)18-19-17-13-7-3-2-6-12(13)10-11-15(17)20/h2-11,20H,1H3/b19-18+
- Substance type:Organic
- Physical state:Solid
Specific details on test material used for the study:
- Name of test material: 1-[(2-methoxyphenyl)diazenyl]-2-naphthol
- Common Name: Solvent Red 1
- Molecular formula: C17H14N2O2
- Molecular weight: 278.31 g/mol
- Smiles notation: c12c(\N=N\c3c(cccc3)OC)c(ccc1cccc2)O
- InChl : 1S/C17H14N2O2/c1-21-16-9-5-4-8-14(16)18-19-17-13-7-3-2-6-12(13)10-11-15(17)20/h2-11,20H,1H3/b19-18+
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: Male and female
- Source: Kuiper’s rabbit ranch, Gary, IN.
- Age at study initiation: No data available
- Weight at study initiation: 2.40 – 2.58 kg
- Fasting period before study: No data available
- Housing: Animals were housed in the appropriate randomly selected cage. Each animal was then assigned a sequential animal number unique within American Biogenics Corporation (ABC) and identified with an ear tag bearing this animal number, The sequential animal number was listed on a cage card that was affixed to the front of the animal's cage. Rooms were cleaned daily and the cages were cleaned and sanitized as specified in ABC SOP's. Urine and feces fell through the wire mesh floor onto animal caging board. The cage boards were changed at least 2 to 3 times per week.
- Diet (e.g. ad libitum): Purina Certified Rodent Chow 5002, ad libitum, except for fasting prior to dosing.
- Water (e.g. ad libitum): Filtered tap water was provided through an automatic watering system and was analyzed periodically, ad libitum.

- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 7 °C
- Humidity (%): 30-70 %
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 6:00 a.m. to 6:00 p.m. (12 hour light/dark, cycle)

IN-LIFE DATES: From: September 16, 1985 To: September 24, 1985

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg (0.1 ml)
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
The treated eye of each animal was examined for ocular irritation and lesions at 24, 48 and 72 hours (+2 hours at each interval). The treated eyes were evaluated on days 7, 14, and 21 if irritation persisted.
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6 (3/sex)
Details on study design:
Details on study design
TEST SITE
- Area of exposure: everted lower lid of the right eye
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

SCORING SYSTEM: according to Draize method
The mean Primary Eye Irritation Score with standard deviation and standard error values were calculated at each evaluation interval using the total scores of each treated eye.

Results and discussion

Other effects / acceptance of results:
no data available
Results of in vivo studyopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
10.7
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
4.7
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0.7
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Redness (grade 1 through 3), chemosis (grade 1 and 2), discharge (grades 1 and 2), and iritis (grade 1) were observed.Blistering of the conjunctivae was noted for all animals. Two animals also exhibited opacities and positive fluorescein staining.

Any other information on results incl. tables

Table 1: Ocular reaction data

 

Time interval

Prior to instillation

24 (± 2) hours

48 (± 2) hours

72 (± 2) hours

 

No of animals

1

2

3

1

2

3

1

2

3

1

2

3

1

 Cornea

 

 

 

 

 

 

 

Density

0

0

0

1

0

1

0

0

0

0

0

0

 

Area

0

0

0

1

0

1

0

0

0

0

0

0

 

A x B x 5

0

0

0

5

0

5

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

Iris

 

 

 

 

 

 

 

 

 

 

 

 

 

Value

0

0

0

1

0

1

0

0

0

0

0

0

 

A x 5

0

0

0

5

0

5

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

Conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

Redness

0

0

0

3

2

2

2

1

1

1

0

0

 

Cherosis

0

0

0

2

2

2

1

0

1

0

0

0

 

Discharge

0

0

0

2

1

2

0

0

0

0

0

0

 

(A + B+ C) x 2

0

0

0

14

10

12

6

2

4

2

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total 1 +2 +3

0

0

0

24

10

22

6

2

4

2

0

0

 

Reaction to fluorescein

 

 

 

1

0

1

0

0

0

0

0

0

 

Mean

0

0

0

10. 7

4.0

0.7

 

S.D.

0

0

0

7.5

2.0

1.2

 

S.E.

0

0

0

4.4

1.2

0.7

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
No mortalities or abnormal clinical signs were observed. Redness (grade 1 through 3), chemosis (grade 1 and 2), discharge (grades 1 and 2), and iritis (grade 1) were observed. Blistering of the conjunctivae was noted for all animals. All animals were considered to have exhibited a positive response to Solvent Red 1.
Hence, Solvent Red 1 can be considered to be irritating to New Zealand White rabbit eyes.
Executive summary:

An eye irritation study was performed on 6 (3/sex) New Zealand White Albino rabbits to assess the irritation potential of Solvent Red 1.

0.1 g of neat Solvent Red 1 was instilled into the eyes of rabbits and the effects were observed. The treated eye of each animal was examined for ocular irritation and lesions at 24, 48 and 72 hours (+2 hours at each interval). The treated eyes were evaluated on days 7, 14, and 21 if irritation persisted. No mortality and clinical signs of toxicity were observed in treated rabbits. Redness (grades 1 through 3), chemosis (grades I and 2), discharge (grades 1 and 2) and iritis (grade 1) were observed. Blistering of the conjunctivae were observed.Blistering of the conjunctivae was noted for all animals. Two animals also exhibited opacities and positive fluorescein staining. All animals were considered to have exhibited a positive response to Solvent Red 1.

 The mean irritation score after 72 hours was 0.7

Hence, Solvent Red 1 can be considered to be irritating to New Zealand White rabbit eyes.