Registration Dossier

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
Study period:
1989-07-04 to 1989-10-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24th February 1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Orange 12

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., Wyton, Huntingdon, England
- Age at study initiation: adult
- Females were nulliparous and not pregnant
- Weight at study initiation: Females: 2.4 – 2.9 kg
- Housing: standardized conventional conditions in individual stainless steel cages. Excrement trays beneath the cages contained low-dust wood shavings (type S 8/18, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Identification of animals: The rabbits were identified by individual ear marks (tattoos) and cage marks.
- Diet (e.g. ad libitum): Diet “Ssniff K4” (Ssniff Spezialdiäten GmbH, Soest, Germany); approx. 100 -120 g per animal and day; feeding once per day in the morning.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: The animals were kept for at least 14 days in the quarantine station of the Department of Laboratory Animal Services before treatment and monitored for diseases (clinical). Shortly after arrival collective faeces specimens were examined for Coccidia oocysts .

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single treatment, 24 h after instillation the treated eye was washed with physiological saline
Observation period (in vivo):
Scoring was conducted after 1, 24, 48, 72 hours and 7 days after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours after instillation

SCORING SYSTEM: according to Draize (see Table 1 in box "Any other information on material and methods incl. tables")

TOOL USED TO ASSESS SCORE: optical tools and fluorescin

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corneal or iridial effects were noted in any treated eye during the study period. For individual results see table 2 in box "Any other information on results incl. tables".

Any other information on results incl. tables

Table 2: Individual Eye Irritation Scores

24 hours 48 hours 72 hours Mean 24/48/72 hours
Animal no. Cornea Iris Conjunctivae Chemosis Cornea Iris Conjunctivae Chemosis Cornea Iris Conjunctivae Chemosis Cornea Iris Conjunctivae Chemosis
1 0 0  0 0 0 0 0 0 0 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute eye irritation/corrosion study according to OECD 405, the test substance does not cause irritant effects in the rabbit eye.
Executive summary:

In a primary eye irritation study conducted according to OECD 405, the test item was instilled into the eye of 3 female New Zealand White rabbits. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

No corneal or iridial effects were noted in any treated eye during the study period.

In this study, the test item is not an eye irritant according to CLP criteria.