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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read across from analogous substance
Adequacy of study:
key study
Study period:
From September 04 to September 11, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Slight modifications from the guidelines (e.g. more accurate description and scoring of corneal defects, additional axamination of aqueosus humor) do not affect the validity of this study.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd. England
- Number of animals: 3
- Female: nulliparus and nonpregnant
- Weight of animals: 3.6 Kg, 3.7 Kg and 4.0 Kg (before the application)
- Randomization: by a number generator software
- Identification: ear marks (tatoo) and cage cards
- Preventive treatment: no vaccinationsor treatment with antibiotics
- Housing: individual stainless steel cages with flat rod bases or plastic cages with perforated bases. Excrement trays beneath the cages contained low-dust (wood) bedding (type S 8/15, Ssniff Spezialdiaten GmbH, Soest). Bedding was regularly spot-checked for contaminants and changed at least twice weekly.
- Diet: ad libitum, Standard diets "Ssniff K 4", (Ssniff Spezialdiaten GmbH, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
- Water: tap water; ad libitum.
- Analytical check of nutritive composition, contaminan-content and water for bacteria and contaminants was performed regularly.
- Acclimation period: at least 14 days. During this period pooled faeces specimens were examined for Coccidia oocysts.
- Observation of animals: daily

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 %
- Air changes (per hr): air-conditioned room, filtered
- Photoperiod (hrs dark / hrs light): 12 hours per day
- Irradiance. 27 Watt/m^2
- Air exchange: 10 times/hour
The humidity and air temperature were continuously recorded using a calibrated thermohygrograph (type 252, Lambrecht Co.,Gottingen).
- Cleanings: at least once per month, except for the room floor which was cleaned once per week, and disinfected with Zephirol® 10 % (1 % in water).
The drinking apparatus was cleaned once a week.

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
100 µl of pulver (approx. 30 mg)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 female
Details on study design:
TEST SITE
- Area of exposure: conjuntival sac of one eye. The lids were gently held together for about one second in order to limit loss of the material. The other eye remained untreated and served as control.

REMOVAL OF TEST SUBSTANCE
- Washing : 24 hours after instillation of the test substance the treated eye was rinsed with saline.

SCORING SYSTEM:
DRAIZE method, and any serious lesions or toxic effects other than ocular irritation, were also recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal: all tested animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: D11 and D8
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: D1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Irritant

Any other information on results incl. tables

Animal n. Weight (kg) Sex Tissue Signs DRAIZE GRADES irritation index
1 h 24 h 48 h 72 h 7 d
D1 3.6 Cornea Opacity 0 1 1 1 0 1.0
Area 0 2 2 2 0
Fluorescin Intensity - 2 2 1 0
Area - 2c 2c 1c 0
Iris 0 0 0 0 0 0.0
Conjunctivae Redness 0 1 2 2 0 1.7
Swelling 3 2 1 0 0 1.0
Aqueous Humor 0 0 0 0 0
Discharge 2 2 1 0 0
D11 3.7 Cornea Opacity 0 0 0 0 0 0.0
Area 0 0 0 0 0
Fluorescin Intensity - 1 0 0 0
Area - 2c 0 0 0
Iris 0 0 0 0 0 0.0
Conjunctivae Redness 0 2 2 2 0 2.0
Swelling 3 3 0 0 0 1.0
Aqueous Humor 0 0 0 0 0
Discharge 2 3 2 0 0
D8 4 Cornea Opacity 0 1 0 0 0 0.3
Area 0 2 0 0 0
Fluorescin Intensity - 1 0 0 0
Area - 2c 0 0 0
Iris 0 0 0 0 0 0.0
Conjunctivae Redness 0 2 2 2 0 2.0
Swelling 2 2 0 0 0 0.7
Aqueous Humor 0 0 0 0 0
Discharge 2 1 0 0 0

c = confluent diffuse areas

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritating to eyes) based on CLP criteria
Conclusions:
Irritant
Executive summary:

Method

The substance was tested according to the OECD Guidelines 405 with slight modifications which do not affect the validity of the test. Moreover the test has been conducted in compliance with the GLP Regulation.

Results

The dyestuff showed in the test condition irritating effects fully reversible within 7 days. The conjunctival redness mean scores following grading at 24, 48 and 72 hours, in 2 of 3 tested animals are positive (Conjunctival redness = 2). Therefore the substance is considered as Irritant for eye.