α,α,α-trifluoro-4-nitro-m-cresol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

to 1990-08-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2012-10-02

Principles of method if other than guideline:

According to Draize

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α,α,α-trifluoro-4-nitro-m-cresol

EC Number:

201-818-2

EC Name:

α,α,α-trifluoro-4-nitro-m-cresol

Cas Number:

88-30-2

Molecular formula:

C7H4F3NO3

IUPAC Name:

α,α,α-trifluoro-4-nitro-m-cresol

impurity 1

Reference substance name:

5-chloro-α,α,α-trifluoro-2-nitrotoluene

EC Number:

204-280-7

EC Name:

5-chloro-α,α,α-trifluoro-2-nitrotoluene

Cas Number:

118-83-2

Molecular formula:

C7H3ClF3NO2

IUPAC Name:

4-Chloro-1-nitro-2-(trifluoromethyl)benzene

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Dihydrogen oxide

impurity 3

Reference substance name:

3-Carboxy-4-nitrophenol

Cas Number:

610-37-7

Molecular formula:

C7H5NO5

IUPAC Name:

3-Carboxy-4-nitrophenol

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

OTHER SPECIFICS: dark brown liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc.
- Age at study initiation: young adult, ~ 14 weeks
- Weight at study initiation: 2.362 - 3.068 kg
- Housing: Individually, in screen-bottm stainless steel cages
- Diet: measured amount, High Fiber Rabbit Chow #5326, Purina Mills, Inc.
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1990-06-14 To: 1990-07-06

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

sinlge treatment

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

In an in vivo study similar to OECD guideline 405, the test substance showed serious eye damaging effects in rabbits.

Executive summary:

In a primary eye irritation study similar to OECD guideline 405, 0.1 mL of the test substance (undiluted test substance) was instilled into one conjunctival sac of one young adult, ~14 weeks old New Zealand White rabbit (2590 g) (Hazleton Laboratories, 1990). No washing procedure was performed. The animal was then observed for 21 days. Irritation was scored by the method of Draize (1959). Based on the individual mean score (24/48/72 h) following scores were determined: Cornea opacity score 4.0, iris score 2.0, conjunctiva score 3.0, chemosis score 2.67.

The test substance was corrosive to the eye based on the individual mean score (24/48/72 h).

Due to the level of irritation observed in this one animal, the other five animals slated for this study were not treated.