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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:
5 Jul. -9 Jul. 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Certain test conditions not specified otherwise a well performed test according to the OECD Guideline 405 (valid in 1993).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guidlines No 405, feb 1987, and Annex to 92/69/EEC of 31/7 92 part B.5.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: SPF albino female rabbits of stock MOL: Russian
Strain:
other: SPF albino female rabbits of stock MOL: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Möllegard Breeding Centre Ltd, Eljby , DK-4623 Lille Skensved Denmark.
- Age at study initiation: Not specified.
- Weight at study initiation: 2.5-2.9 kg
- Fasting period before study: No fasting period.
- Housing: Cages PPL 45x55 cm with perforated floor, single in each cage.
- Diet (e.g. ad libitum): ad libitum diet Altromin 2123
- Water (e.g. ad libitum): Water acidified with HCl to pH 2.5
- Acclimation period: Not specified.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes (per hr):10 times/day
- Photoperiod (hrs dark / hrs light):12 hrs light/12 hrs dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): solid sample

Duration of treatment / exposure:
The eyes were held together 1 sec. after application. Only one eye was tested.
Observation period (in vivo):
24 hrs before application both eyes were controlled by inspection light and UV-light and magnifying glass (2 degrees of magnification).

Examination 1 hrs after application and after 24 hrs a new examination. Instillation of oculoguttae fluoresceni in the eyes and after that rinsing with 20 ml 0.9 % sodium chloride and examination with UV-light to detect possible damage. New examination 48 and 72 hrs after the application of the test substance.
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With 0.9 % Sodium Chloride solution 24 hrs after first examination.
- Time after start of exposure: 25 hrs

SCORING SYSTEM: See table "Results and discussions" below.. Scoring according to the OECD Guideline.

TOOL USED TO ASSESS SCORE: hand-slit lamp / magnifying glass (2 degrees) / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24 hrs
Score:
0.3
Max. score:
2
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
1
Remarks on result:
other: Max. duration: 1 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The conclusion of the registrant is that Gelpaste Urea is not an eye irritant.