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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
in vivo study performed prior to REACH implementation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 - 21 February 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridine-2-carbaldehyde oxime
EC Number:
212-849-6
EC Name:
Pyridine-2-carbaldehyde oxime
Cas Number:
873-69-8
Molecular formula:
C6H6N2O
IUPAC Name:
pyridine-2-carbaldehyde oxime
Test material form:
other: whitish crystals
Details on test material:
- Name of test material (as cited in study report): Pyridin-2-aldoxim
- Physical state: whitish crystal
- Analytical purity: minimum 98%
- Purity test date : no data
- Lot/batch No.: no data
- Stability under test conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG , 4414 Fuellinsdorf , Switzerland
- Age at study initiation: 15-16 weeks
- Weight at study initiation: 2.6 - 2.8 kg
- Housing: The animals were caged individually in stainless steel cages , with automatic drinking water supply and cleaning system
- Diet (e.g. ad libitum): rabbit maintenance diet (standard Kliba 341 (Klingentalmühle AG , 4303 Kaiseraugst , Switzerland) , ad libitum
- Water (e.g. ad libitum): tap water , ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
0.1 g of powder for each animal was placed into the conjunctival sac
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/rabbit
Observation period (in vivo):
At 1, 24, 48 and 72 hours post application.
The observation was terminated 72 hours after administration of the test article .
Number of animals or in vitro replicates:
3 (1 male / 2 females)
Details on study design:
A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 g per animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was not washed after treatment

OBSERVATIONS
- Viability / Mortality : Daily.
- Body Weights : Day 1 and at termination of test on a Mettler PK 16 balance.
- Symptoms : The eyes of each animal were examined 1-, 24-, 48- and 72 hours after administration. The irritation was assessed according to the OECD Guidelines for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
The corrosive properties of the test article and the colour of the treated eye were described and recorded.

TOOL USED TO ASSESS SCORE: slit lamp 30 SL (C. Zeiss AG , Zuerich/Switzerland) and Varta Cliptrix diagnostic-lamp (A. Riegger , Basel/Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24,48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24,48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24,48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Pyridin-2-aldoxim showed a primary irritation score of 0.8 when applied to the rabbit eye mucosa. No corrosion of the cornea was observed at each of the measuring intervals. In the area of application no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study was performed according to the OECD TG405 without deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. The test material did induce only slight reversible irritation on rabbit eyes. The test material was considered to be not irritating under the conditions of the test.
Executive summary:

The test substance Pyridin-2-aldoxim was investigated for its potential to cause irritation in the rabbit eye according to OECD TG405. 0.1 g of pure substance were instilled into the conjunctival sac, the untreated eye served as control. Under the conditions of this experiment Pyridin-2-aldoxim was found to cause no irritation when applied to the rabbit eye mucosa. No corrosion effect was observed at each of the measuring intervals. No discoloration of the cornea and conjunctivae which could be related to effects of the test material was observed. Additionally no corrosive or acute toxicological signs were observed in the animals during the test period. According to classification criteria in the European regulation (EC) No. 1272/2008, amending regulation EC no. 1907/2006 (REACH) the test substance is not irritating to eyes and should be unclassified.