Registration Dossier
Registration Dossier
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EC number: 200-441-0 | CAS number: 59-67-6
Eye irritation
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
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC AG
Test material
- Reference substance name:
- Nicotinic acid
- EC Number:
- 200-441-0
- EC Name:
- Nicotinic acid
- Cas Number:
- 59-67-6
- Molecular formula:
- C6H5NO2
- IUPAC Name:
- nicotinic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Nicotinic acid
Constituent 1
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.
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