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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(o-nitrophenyl)azo]-p-cresol
EC Number:
215-863-0
EC Name:
2-[(o-nitrophenyl)azo]-p-cresol
Cas Number:
1435-71-8
Molecular formula:
C13H11N3O3
IUPAC Name:
4-methyl-2-[(2-nitrophenyl)diazenyl]phenol
Details on test material:
- Identification: TK 40136
- Product name: Monoazo 3113
- Physical state: Red-brownish solid
- Analytical purity: > 95%
- Lot/batch No.: Pa 369
- Expiration date of the lot/batch: November 01, 1997
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, Netherlands
- Age at study initiation: Approx. 7 weeks
- Weight at study initiation: 1541 - 1856 grams
- Housing: single
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, Netherlands); approx. 100 g per day; in addition, hay (BMI, Helmond, the Netherlands) was provided once a week;
- Water: Free access to tap-water diluted with decalcified water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 47+/- 0.9 mg of test substance (a volume of approximately 0.1 ml)
Duration of treatment / exposure:
see observation period, no washing out conducted
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male animals
Details on study design:
SCORING SYSTEM: according to OECD 405 / Draize; from the maximum (mean) Draize score, an eye irritation rating was obtained based on: Draize, Woodard & Calvery (1944) J.Pharmacol.Exp.Ther. 82, 377; Kay & Calandra (1962) J.Soc.Cosmet.Chem. 13, 281;


TOOL USED TO ASSESS SCORE: Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area. In case standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: see table below for details
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
other: see table below for details
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
3
Reversibility:
other: no effects observed
Remarks on result:
other: redness (score 1) observed at the 1 hour-reading in all 3 animals; reversible within 24 hours; see table below for details
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: chemosis (score 1) observed in 1 animal at the 1 hour-reading; reversible within 24 hours; see table below for details;
Irritant / corrosive response data:
Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
Other effects:
Remnants of the test substance were noted on the outside of the eyelids of all animals throughout the study period. No signs of systemic intoxication were observed during the study period.

Any other information on results incl. tables

Animal  Reading  Cornea Iris Conjunctiva  
Opacity Area involved Redness Chemosis Discharge Comment
1 1 h 0 0 0 1 0 1 Remnants of the test substance in the eye/on the outside of the eyelids
2 1 h 0 0 0 1 0 1 Remnants of the test substance in the eye/on the outside of the eyelids
3 1 h 0 0 0 1 1 1 Remnants of the test substance in the eye/on the outside of the eyelids
1 24 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
2 24 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
3 24 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
1 48 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
2 48 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
3 48 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
1 72 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
2 72 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
3 72 hrs 0 0 0 0 0 0 Remnants of the test substance on the outside of the eyelids
1 24/48/72 hrs 0   0 0 0    
2 24/48/72 hrs 0   0 0 0    
3 24/48/72 hrs 0   0 0 0    
mean animal 1-3 24/48/72 hrs 0   0 0 0    

The maximum (mean) Draize score was 4.7.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is considered not irritant to eyes.