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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1990-02-20 to 1990-03-14
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:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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
- Physical state: 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:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 8-9 weeks
- Weight at study initiation: Cfr. Table 2
- Fasting period before study: Overnight
- Housing: stainless steel cages, groups of max. 3 of same sex
- Diet (ad libitum): pelleted diet (LAD 1, Special Diets Service Ltd.)
- Water (ad libitum): public supply water
- Acclimation period: min. 4 days
- On the day before dosing, the dorsal fur was removed using electric clippers.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1991-12-09 To: 1991-12-24

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6x8 cm
- % coverage: 100
- Type of wrap if used: waterproof adhesive type

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm ditlute detergent solution
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.89 ml/kg body weight
- Concentration (if solution): undiluted
- Constant volume or concentration used: no
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 males and 5 females/sex
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 5 observations on the day of dosing and twice daily thereafter; body weights on days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: not applicable
- Euthanasia by i.p. injection of sodium pentobarbitone.
Statistics:
Not applicable

Results and discussion

Preliminary study:
A preliminary test utilising one male and one female rat treated at 2000 mg/kg indicated that the acute median lethal dermal dose (LD50) was greater than 2000 mg/kg.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Brake fluid DOT 4 Super
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 520 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: B-TTEGME
Mortality:
No mortality.
Clinical signs:
No clinical signs. There were no signs of systemic reaction to treatment. Sites of application showed no irritation or other dermal changes.
Body weight:
All rats had gained weight relative to their day 1 body weight by the end of the 14 day observation period.
Gross pathology:
No macroscopic changes at the time of necropsy. Sites of appliation of the test material showed no irritation or other dermal change.
Other findings:
Not applicable.

Any other information on results incl. tables

Table 2. Body weights in males and females (gram)

Male No.

Body weight

Body weight change

 

Female No.

Body weight

Body weight change

Day 1

Day 8

Day 15

 

Day 1

Day 8

Day 15

858 M

206

+1

+15

 

858 F

142

+6

+16

859 M

213

+8

+19

 

859 F

150

+4

+16

860 M

221

+3

+22

 

860 F

141

+5

+18

861 M

219

+3

+16

 

861 F

151

+6

+17

862 M

208

+7

+20

 

862 F

153

+6

+16

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute dermal LD50 of Brake fluid Dot 4 in rats was greater than 2000 mg/kg body weight, corresponding with 1520 mg B-TTEGME/kg.
Executive summary:

Brake Fluid DOT4 Super is considered to have a similar toxicological profile as B-TTEGME. The acute dermal LD50 of Brake fluid Dot 4 Super (containing 76 % B-TTEGME) in fasted rats was greater than 2000 mg/kg body weight, corresponding to more than 1520 mg B-TTEGME/kg body weight. The test material was applied undiluted to the clipped dorsum at 1.88 ml/kg body weight, corresponding to 2000 mg/kg body weigth, and kept in place under occlusive dressing for 24 hours. All five male and five female rats survived without clinical signs. All rats had gained weight relative to their day 1 body weight by the end of the 14 day observation period. No macroscopic changes were apparent during necropsy of the treated rats on Day 15.