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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1990-02-26 to1990-03-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is well documented and performed according to generally valid and/or internationally accepted testing guidelines. The test material contained a high percentage of the test substance.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The eyes were examined at 1h,4h,24h,48h 72h and 7 days, on 6 rabbits.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Brake Fluid DOT 4 Super containing B-TTEGME
IUPAC Name:
Brake Fluid DOT 4 Super containing B-TTEGME
Details on test material:
- Name of test material (as cited in study report): Brake fluid DOT 4 Super
- Substance type: Borated Glycol Ether
- Physical state: Clear colourless liquid
- Analytical purity: 76% B-TTEGME
- Impurities (identity and concentrations): Confidential details on test material
- Composition of test material, percentage of components: Confidential details on test material
- Purity test date: Not provided
- Lot/batch No.:1. kSLA Ref. 7842/89 (0.0039); Toxicology ref No. ST90/023
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms U.K. Ltd.
- Age at study initiation: 3-5 monhts
- Weight at study initiation: 2.94-3.65 kg
- Housing: stainless steel cages 91x 66 x 45 cm.
- Diet: pelleted standard rabbit diet S.Q.C., Special Diets Services, Ltd., ad libitum
- Water: public supply, ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-20
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1990-02-26 To: 1990-03-13

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0,1 ml undiluted test material
Duration of treatment / exposure:
The treated eye was gently held closed for a few seconds to prevent loss of the test material.
Observation period (in vivo):
1h,4h,24h,48h,72h and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
The undiluted test material (0,1 ml) was placed into the lower conjunctival sac of one eye of each animal. The treated eye was gently held closed for a few seconds to prevent loss of the test material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: directly

SCORING SYSTEM: The immediate reactions of the rabbits were scored as an initial pain response using a six point scale:
1. No initial pain
2. Practically no initial pain
3. Slight initial pain
4. Moderate initial pain
5. Severe initial pain
6. Very severe initial pain
The other reactions were scored using standard grades according to OECD.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: brake fluid
Irritation parameter:
chemosis score
Remarks:
sometimes associated with slight ocular discharge
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: brake fluid
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: brake fluid
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: brake fluid
Irritant / corrosive response data:
slightly irritant

Any other information on results incl. tables

 Table 1. Eye irritation testing in rabbits

Animal No.

Sex

Response

1 hour

4 hours

24 hours

48 hours

72 hours

7 days

927

M

Redness

1

1

1

0

0

0

Chemosis

1a

1a

0

0

0

0

Opacity

0

0

0

0

0

0

Iris

0

0

0

0

0

0

928

M

Redness

1

1

1

0

0

0

Chemosis

1a

1a

1

0

0

0

Opacity

0

0

0

0

0

0

Iris

0

0

0

0

0

0

929

M

Redness

1

1

1

0

0

0

Chemosis

1a

1a

1

0

0

0

Opacity

0

0

0

0

0

0

Iris

0

0

0

0

0

0

969

F

Redness

1

1

1

0

0

0

Chemosis

1a

1a

1

0

0

0

Opacity

0

0

0

0

0

0

Iris

0

0

0

0

0

0

970

F

Redness

2

2

1

0

0

0

Chemosis

1a

2a

1

0

0

0

Opacity

0

0

0

0

0

0

Iris

0

0

0

0

0

0

971

F

Redness

1

2

1

0

0

0

Chemosis

1a

2a

1

0

0

0

Opacity

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Mean Redness score

1.2

1.3

1.0

0.0

0.0

0.0

Mean Chemosis score

1.0

1.3

0.8

0.0

0.0

0.0

Mean Opacity score

0.0

0.0

0.0

0.0

0.0

0.0

Mean Iris score

0.0

0.0

0.0

0.0

0.0

0.0

a – Slight ocular discharge

 

Table 2. Mean scores

Group mean 24, 48 & 72 hours

Redness

0.3

Chemosis

0.3

Opacity

0.0

Iris

0.0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight conjunctival irritation irritation with redness, chemosis and ocular discharge. The changes resolved within 48 hours of treatment. The cornea and iris were not visibly affected by the test material.
Executive summary:

Brake Fluid DOT 4 Super is considered to have a similar toxicological profile as B-TTEGME. Brake fluid Dot 4 Super (containing 76% B-TTEGME) was applied undiluted (at 0,1mL) in 3 male and 3 female rabbits. Conjunctival irritation led to a crimson-red appearance and chemosis sufficient to cause partial eversion of the eye lids and ocular discharge. These resolved within 48 hours of treatment. The cornea and iris were not visibly affected by the test material. Upon administration of the test material there was a moderate initial pain response. The ocular findings however were not significant for classification.