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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 18501990-03-14
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 401 (Acute Oral 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
- 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. 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: see Table 4
- Fasting period before study: Overnight up to 3h after dosing
- 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

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: 1990-02-20 To: 1990-03-14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: not applicable (undiluted Brake fluid DOT4 Super)
DOSE VOLUME APPLIED: 4.70 ml/kg
CLASS METHOD: limit dose
Doses:
PRELIMINARY TEST: 2000 & 5000 mg/kg
MAIN TEST: 5000 mg/kg body weight
No. of animals per sex per dose:
PRELIMINARY TEST: 1 male and 1 female/dose
MAIN TEST: 5 males and 5 females/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations & weighing: detailed clinical examination 5 x on the day of dosing & twice daily thereafter; body weight on day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: no
- Terminal kill by IP injection of sodium pentobarbitone.
Statistics:
Not applicable

Results and discussion

Preliminary study:
The preliminary test utilising groups of 1 male and 1 female rat treated at 2000 and 5000 mg/kg indicated that the acute median lethal oral dose (LD50) was greater than 5000 mg/kg.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: brake fluid
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 800 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: B-TTEGME
Mortality:
After application of 5000 mg/kg body weight no deaths in male and female animals occured during the 14 day observation period.
Clinical signs:
The sole common sign of reaction to treatmentwas a hunched posture apparent from within 1 hour of dosing. Other isolated clilnical signs were lachrymation, abasia, lethargy, unkempt appearance and encrustation of the periorbital zone. Recovery, as judged by external appearance and behavior, was complete by day 3.
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 were apparent during necropsy of the treated rats on Day 15.
Other findings:
Not applicable

Any other information on results incl. tables

Table 2. Clinical observations in males

Clinical sign

Animal No. & sex

Time of first detection

Time of recovery

853 M

854 M

855 M

856 M

857 M

Lachrymation

-

-

-

-

-

 

 

Hunched back

+

+

-

-

-

1h

Day 3

Lethargy

-

-

-

-

-

 

 

Abasia

-

-

-

-

-

 

 

Periorbital zone – encrustation

+

-

-

-

-

0.5h

Day 2

Unkempt appearance

+

+

-

-

-

Day 2

Day 3

 

Table 3. Clinical observations in females

Clinical sign

Animal No. & sex

Time of first detection

Time of recovery

853 F

854 F

855 F

856 F

857 F

Lachrymation

-

-

-

-

+

2.7h

4h

Hunched back

+

+

+

+

+

1h

Day 2

Lethargy

-

-

+

-

+

1h

5h

Abasia

-

-

-

-

+

0.5h

1h

Periorbital zone – encrustation

-

-

-

-

-

 

 

Unkempt appearance

-

-

-

-

-

 

 

Table 4. 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

853 M

181

+32

+40

 

853 F

133

+19

+24

854 M

193

+24

+34

 

854 F

137

+24

+26

855 M

183

+33

+44

 

855 F

136

+26

+30

856 M

175

+34

+49

 

856 F

130

+22

+28

857 M

187

+28

+40

 

857 F

134

+20

+27

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
LD50 > 5000 mg/kg body weight Brake fluid DOT 4 Super, corresponding with 1850 mg/kg body weight B-TEGME.
Executive summary:

Brake Fluid DOT4 Super is considered to have a similar toxicological profile as B-TTEGME. The acute oral LD50 of Brake fluid Dot 4 Super in fasted rats was greater than 5000 mg/kg body weight, corresponding to greater than 3800 mg B-TEGME/kg body weight. The undiluted test material was administered by oral gavage at 4.70 mL/kg body weight. Five male and five female rats were dosed at 5000 mg/kg and all survived. The sole common sign of reaction to treatmentwas a hunched posture apparent from within 1 hour of dosing. Other isolated clinical signs were lachrymation, abasia, lethargy, unkempt appearance and encrustation of the periorbital zone. Recovery, as judged by external appearance and behavior, was complete by day 3. 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.