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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
In vivo eye irritation study available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14th December 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed accordingly to the OECD Guideline No. 405 and in compliance with the GLP. Moreover, the information on the test substance is available.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Curb Powder, Aluminium ammonium sulfate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeding Facility, Jai Research Foundation, India
- Age at study initiation: no data
- Weight at study initiation: 2.57 to 2.67 kg
- Fasting period before study: No data
- Housing: individual, in stainless steel wire cages. 45.7 cm breadth x 60.9 cm lenght x 45.7 cm height.
- Diet (e.g. ad libitum): ad libitum; rabbit pellet diet (Amrut brand) manufactured by Pranav Agro Industries Limited, Pune, Mahashtra, India
- Water (e.g. ad libitum): ad libitum in a polypropylene water bottle with a stainless steel nozzle. The drinking water was filtered through Aquagard water filter system.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22 °C
- Humidity (%): 65%
- Air changes (per hr): 17 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h artificial light / 12 h darkness

IN-LIFE DATES:

Test system

Vehicle:
water
Controls:
other: Both control and treated eyes for each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of Aluminium ammonium sulfate
- Concentration (if solution): no data

VEHICLE
no data
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three adult males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): both eyes (control and treated) of all rabbits were washed with distilled water
- Time after start of exposure: 24h after instillation of the test substance

SCORING SYSTEM: The irritant response was scored following the method provided by the guidelines of the OECD N°405.

TOOL USED TO ASSESS SCORE: fluorescein: the eyes of each animal were examined using fluorescein dye staining (Swinyard, 1990).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
The mean individual scores were presented in the Table 7.3.2/1 (below).
Other effects:
At 1 h after treatment, slight redness (some blood vessels definitely hyperaemic) was observed in treated eyes of two rabbits and diffused crimson colour with individual blood vessels not easily discernible was observed in one rabbit.

At 24h after treatment, chemosis (swelling above normal) and redness (diffused crimson colour with individual blood vessels not easily discernible) was observed in treated eye of all rabbits. Examination with fluorescein dye and cobalt blue filter (corneal damage showing as green fluorescein) revealed damage to 1/4 corneal epithelium of the treated eye of two rabbits.

At 48h after treatment, redness (some blood vessels definitely hyperaemic) and chemosis (swelling above normal) was observed in treated eye of two rabbits.

At 72h after treatment, treated eyes of all rabbits appeared normal.

No abnormalities were detected in the control eye of the rabbits during the course of the study. No damage to corneal epithelium was observed during the examination with fluorescein dye and cobalt blue filter.

No clinical signs related to treatment other than eye irritations were observed in any of the three rabbits.

Any other information on results incl. tables

Table 7.3.2/1: Mean Individual Eye Irritation Scores For EEC Classification

Rabbit No

Mean individual scores at 24, 48 and 72 hours

Corneal opacity

Iris lesion

Conjunctivae redness

Conjunctivae chemosis

1

0

0

1

0.67

2

0

0

1

0.67

3

0

0

0.67

0.33

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, aluminium ammonium sulfate is not classified as irritant to eyes according to the criteria of the Annex VI to the CLP Regulation and the 67/548/EEC Directive.
Executive summary:

In an eye irritation study, aluminium ammonium sulfate as powder was applied by instillation (0.1 g) in eyes to 3 adult males New Zealand white rabbits. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 405 (Acute Eye Irritation) and EC B.5.

After treatment with Aluminium ammonium sulfate, the eyes of all animals were observed for signs of ocular irritation at 1, 24, 48 and 72 hours. For each observation, scoring for ocular lesions was undertaken for the cornea, the iris and the conjunctiva.

At 1 h after treatment, slight redness was observed in treated eyes of two rabbits and diffused crimson colour with individual blood vessels not easily discernible was observed in one rabbit.

At 24h after treatment, chemosis and redness was observed in treated eye of all rabbits. Examination with fluorescein dye and cobalt blue filter revealed damage to 1/4 corneal epithelium of the treated eye of two rabbits.

At 48h after treatment, redness and chemosis was observed in treated eye of two rabbits.

At 72h after treatment, treated eyes of all rabbits appeared normal.

No abnormalities were detected in the control eye of the rabbits during the course of the study. No damage to corneal epithelium was observed during the examination with fluorescein dye and cobalt blue filter.

No clinical signs related to treatment other than eye irritations were observed in any of the three rabbits

No corneal and iridal lesion was observed (mean individual score at 0.0). The mean individual scores for the conjuntivae were 1.0 -1.0 -0.67 for the redness and 0.67 -0.67 -0.33 for the chemosis.

Under the test conditions, aluminium ammonium sulfate is not classified as irritant to eyes according to the criteria of the Annex VI to the Regulation (EC) N°1272/2008 and the 67/548/EEC Directive.

This study is considered as acceptable and satisfies the requirement for the irritation toxicity endpoint.