Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Common name (active ingredient): Sulfur
Test substance/item: Sulphur 98.5% DP
Name to be used in report: Sulfur Dust
Chemical name (IUPAC): sulfur
CAS number: 7704-34-9
Batchno and lotno: I-GLA
Manufactured by: SAPEC Agro S.A.; Rua Victor Cordon, 19 1200-482 LISBOA - Portugal
Supplied by: ChemService srl Via F.Ili Beltrami 15; 20026 Novate Milanese (MI) - Italy
Purity: 98.5% w/w
Bulk density: 0,84 g/ml
Physical appearance: yellow powder
Storage conditions: ambient (+18 to +36°C)
pH: 7.8 (at 1% w/v in double distilled water)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Animals: New Zealand white rabbits
Source: Toxicology Department, Rallis Research Centre, Bangalore 560 058, India
No. of rabbits: three male rabbits
Date of birth: 18.09.2004
Age at treatment: 9 months
Body weight range at treatment: 2.88 to 3.21 kg
Identification: By animal accession number, cage label and crystal violet body marking
Rabbit accession numbers: RB5387 - RB5389
Justifiction of selection of test system: Although a variety of experimental animals can be used it is recommended that testing should be performed using healthy adult albino rabbits. Commonly used laboratory strain was used.
Justification for route of administration: In the assessment and evaluation of toxic characteristic of an item, determination of irritant and/or corrosive effects on eyes of mammals is an important step. It provides information on health hazards likely to arise from exposure to eyes and associated mucous membranes. The data from an acute eye irritation study is used for classification and labeling.
Acclimatization: One rabbit R65387 was acclimatized for 6 days while the other two (RB5388 and RB5389) rabbits were acclimatized for 7 days under laboratory conditions after veterinary examination.
Housing: Animals were housed individually in all stainless steel rabbit cages (size: approximately L 45 x B 45 x H 35 cm) with wire mesh bottom and litter trays, having facilities for pelletted diet and drinking water. The litter trays were washed daily with water (except on Sunday).
Diet: The animals were offered rabbit feed manufactured by Nav Maharashtra Chakan Oil Mills Ltd., Pune - 30, Maharashtra, INDIA, ad libitum.
Water: The animals were provided deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai - 400 001, INDIA, ad libitum.

ENVIRONMENTAL CONDITIONS
Air conditioned with adequate fresh air supply (12 - 15 air changes/hour),
Temperature: 20 - 23°C,
Relative humidity: 30 - 70%,
Photo period: 12 hour light and 12 hour dark cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and served as the reference control
Amount / concentration applied:
On test day one, a quantity of 84 mg (equivalent to 0.1 ml of test item (bulk density is 0.84 g/ml)) of the finely ground test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lids were held together gently for about one second to prevent loss of test item.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours post-installation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
After 24 hours contact period, the treated eye was irrigated with de-ionised water for two minutes to remove the residual test item if any. Similarly the control eye was also irrigated with de-ionised water. The score after 24 hours indicated that the test item was not corrosive/severe irritant to the eye.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no adverse reaction present
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: no adverse reaction present
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.28
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Redness of (score 1 to 2) was observed at 24 and 48 hours of post instillation. Chemosis of score 1 was observed at 24 and 48 hours of post instillation. Discharge (score 1 to 2) was observed at 1, 24 and 48 hours post instillation. There was no corneal and iris reaction.
Other effects:
There were no toxic signs and pre-terminal deaths .
The body weights of all rabbits increased through the observation period.
There was no abnormality detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the observations in the study, sulfur does not require classification as an eye irritant.
Executive summary:

In a study in compliance with OECD guideline 405 and under GLP, eye irritation study (Rallis Research Centre, 2005), 84 mg (equivalent to 0.1 ml) of sulfur dust was instilled into the conjunctival sac of the left eye of three male NZW rabbits. The degree of irritation/corrosion was evaluated and scored at 1, 24, 48 and 72 hours post-instillation. The mean (24, 48 and 72 hrs) conjunctivae and chemosis scores were 0.44 and 0.28, respectively (the effects were fully reversible within 72 hours). Discharge (score 1 to 2) was observed at 1, 24 and 48 hours post instillation. There was no corneal and iris reaction.

The findings demonstrate that sulfur does not require calssification as an eye irritant.