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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
RCC AG

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: Nicotinic acid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: Stainless steel cages
- Diet: Ad libitum
- Wate: Ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 /+- 10 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 16 Aug. 1983 To: 23 Aug. 1983

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g/animal
Duration of treatment / exposure:
Eyes were not rinsed after treatment.
Observation period (in vivo):
The eyes were examined and the grade of ocular reactions recorded at 1, 24, 48, 72 hours and at 7 days after treatment.
Number of animals or in vitro replicates:
3 (2 males/1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were not rinsed

SCORING SYSTEM:
- Draize, 1959. Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.
- ETAD (Ecological And Toxicological Association of the Dye Stuffs Manufacturing Industry) Methods 001-003 (1979)
- VCI (Verband Der Chemischen Industrie, BRD) Sicherheitsdatenblatt

TOOL USED TO ASSESS SCORE:
- Hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
IRRITATION
The test item showed irritation when applied on the rabbit eye mucosa.
COLORATION
No discoloration of the cornea and conjunctivae related to effects of the test article was observed in the rabbits during the treatment and observation intervals.
CORROSION
No corrosion of the cornea was observed at each of the measuring intervals.
Other effects:
BODY WEIGHTS
The body weight gain of all rabbits was similar.
TOXIC SYMPTOMS
No acute toxicological signs were observed in the animals during the test period, and no mortality occurred.
NECROPSY
Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this experiment the test item was found to cause a moderate irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae which could be related to effects of the test article was observed. No corrosion was observed at each of the measuring intervals.
The maximum mean total score was found to be: 4.9 (unrinsed eyes). The body weight gain of all rabbits was similar. No systemic effects were observed.
Executive summary:

A study according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) was carried out. A group of 3 rabbits (New Zealand White) were administered 0.1 g of test item into one eye. The untreated eye served as control. Treated eyes were not washed following application. Animals were observed 1, 24, 48 and 72 hours as well as 7 days after treatment.

Under the conditions of this experiment, the test item was found to cause moderate irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae which could be related to effects of the test article was observed. No corrosion was observed at each of the measuring intervals. The body weight gain of all rabbits was similar. No systemic effects were observed.