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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:
From 23 OCT 1984 to 30 OCT 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

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:
o-anisidine
EC Number:
201-963-1
EC Name:
o-anisidine
Cas Number:
90-04-0
Molecular formula:
C7H9NO
IUPAC Name:
2-methoxyaniline
Details on test material:
- Name of test material (as cited in study report): Echtrot BB Base flüssig

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Weight at study initiation: 2.8 to 3.2 kg
- Housing: single caged in fully conditioned rooms
- Diet: Altromin 2123 rabbit diet (Altromin GmbH, Lage/lippe, Germany), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological solution of sodium chloride (37°C)
- Time after start of exposure: 24 h (and at every reading when discharge of the eyes occurred or sodium-fluorescin was used for scoring)

SCORING SYSTEM: according to OECD TG 405


TOOL USED TO ASSESS SCORE: at 48 and 72 h reading 1 drop of sodium-fluorescein (0.1%) added for scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: no signs of irritation at any time
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: no signs of irritation at any time (without fluorescein)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: no signs of irritation at any time (without fluorescein)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: no signs of irritation at any time
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: no signs of irritation at any time
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
1.3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
1.3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: initial, slight reactions were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: initial, slight reactions were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
- 1 h post application: 3/3 animals revealed chemosis scores 1 as well as conjunctivae scores (redness) of 2, all animals had clear lacrimation
- 24 h post application: chemosis as well as conjunctival redness already decreased, only 1/3 animal had a chemosis score of 2, 2/3 animals had a chemosis score of 0; conjunctival scores were 2 in 2/3 animals and score 1 in 1/3 animals, 1/3 animals had white and mucous lacrimation, no lacrimation observed in the other animals
- 48 h post application: further decline of conjunctival scores: 1/3 animals score = 2, 2/3 animals score = 1
- 72 h post application: conjunctival scores: 1/3 animals score = 0, 2/3 animals score = 1
-7 d post application: no visible signs of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test, the test substance is not eye irritating. The test material contains relevant amounts of the submission substance. Therefore the test results are adequate to fulfil the endpoint requirements.
Executive summary:

Test material "Echtrot BB Base flüssig" was subject to an acute eye irritation/corrosion test in 3 New Zealand White rabbits according to OECD TG 405. After the instillation of 0.1 ml of the undiluted test material into each rabbits left conjunctival sac only minor effects were seen in all animals (cornea score: 0; iris score: 0 -1; conjunctivae score (redness): 0 -2; chemosis score: 0 -2). These effects were fully reversible until the 7 d reading. Based on these findings, the test substance is not eye irritating.

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