Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin 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 to 1990-03-06
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
Deviating from OECD 404, six instead of 3 animals were used with a maximal observation period of 7 days.
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.: 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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: 1990-03-06

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml undiluted
Duration of treatment / exposure:
4 hours
Observation period:
0.5, 24, 48, 72 hours and 7 days
Number of animals:
6
Details on study design:
TEST SITE
- On the day before dosing, the dorsal fur was removed using electric clippers.
- Area of exposure: a 6 cm2
- % coverage: 100% on lint patch covered with gauze
- Type of wrap if used: semi-occlusive elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Erythema and oedema were each scored on a five point scale
Erythema and Eschar Formation
- No erythema ...0
- Very slight erythema (barely perceptible) ...1
- Well defined erythema ...2
- Moderate to severe erythema ...3
- Severe erythema (beef redness) to eschar formation preventing grading of erythema...4
Oedema Formation
- No oedema...0
- Very slight oedema (barely perceptible) ...1
- Slight oedema (edges of area well defined by definite raising) ...2
- Moderate oedema (raised approximately 1 mm) ...3
- Severe oedema (raised more than 1 mm and extending beyond area of exposure) ...4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: brake fluid
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: brake fluid
Irritant / corrosive response data:
No irritation or other dermal change.

Any other information on results incl. tables

Table 1. Dermal irritation testing in rabbits

Animal No.

Sex

Response

0.5 hour

24 hours

48 hours

72 hours

7 days

925

M

Erythema

0

0

0

0

0

Oedema

0

0

0

0

0

926

M

Erythema

0

0

0

0

0

Oedema

0

0

0

0

0

930

M

Erythema

0

0

0

0

0

Oedema

0

0

0

0

0

957

F

Erythema

0

0

0

0

0

Oedema

0

0

0

0

0

958

F

Erythema

0

0

0

0

0

Oedema

0

0

0

0

0

959

F

Erythema

0

0

0

0

0

Oedema

0

0

0

0

0

Mean Erythema score

0.0

0.0

0.0

0.0

0.0

Mean Oedema score

0.0

0.0

0.0

0.0

0.0

Table 2. Mean scores

Group mean 24, 48 & 72 hours

Erythema

0.0

Oedema

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No irritation or other dermal change.
Executive summary:

Brake Fluid DOT 4 Super is considered to have a similar toxicological profile as B-TTEGME. Brake fluid DOT 4 Super was tested by semi-occluded topical application of 0.5 ml undiluted test material to the clipped dorsum of six rabbits for 4 hours. This corresponded to 0.375 ml B-TTEGME, assuming that Brake fluid DOT 4 and B-TTEGME have approximately the same density. No irritation or other dermal change was observed up to 7 days after administration.