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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-03-01 to 1995-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
31 July 1992
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Partie 24, 05-Jan-1995; Product number / code: LP 1941
- Substance type: Borated Glycol Ether
- Expiration date of the lot/batch: stable until 05-Jul-1995
- Purity test date: Not provided
- Analytical purity: 97% (calculated after titration of boric acid)

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Hoe: WISKf (SPF71)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breed
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 181-187 g (M); 160-169 g (F)
- Fasting period before study: from about 16 hours before to 3-4 hours after treatment
- Housing: macrolon cages (type 4)
- Diet: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1995-03-01 To 1995-03-15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: not applicable (undiluted)
VOLUME APPLIED: 1.85 mL/kg (density = 1.08 kg/l at 20°C)
CLASS METHOD: limit dose
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations twice every day (in the morning and in the afternoon), on weekends and holidays only once; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
Mean values & standard deviation were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
After application of 2000 mg/kg body weight no deaths in male and female animals occurred during the 14 day observation period.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
Development of body weight was not impaired.
Gross pathology:
The animals were killed at the end of the observation period showed no macroscopically visible changes.

Any other information on results incl. tables

Table 2. Body weight and body weight gain (gram)

Male No.

Body weight

Body weight gain

Day 1

Day 8

Day 15

Day 0

Day 8

Day 15

1

187

251

280

0

64

93

2

182

245

285

0

63

103

3

185

244

280

0

59

95

4

181

239

275

0

58

94

5

182

246

285

0

64

103

Mean

183.4

245.0

281.0

0

61.6

96.6

S.D.

2.5

4.3

4.2

 

2.9

5.0

 

Female No.

Body weight

Body weight gain

Day 1

Day 8

Day 15

Day 0

Day 8

Day 15

1

160

190

204

0

30

44

2

164

190

198

0

26

34

3

169

191

217

0

22

48

4

165

199

213

0

34

48

5

163

186

204

0

23

41

Mean

164.2

191.2

207.2

0

27.0

43.0

S.D.

3.3

4.8

7.7

 

5.0

5.8

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 2000 mg/kg body weight B-TEGME.
Executive summary:

In an oral acute toxicity study according to OECD 401, 5 male and 5 female animals were gavaged with the limit dose of 2000 mg/kg bw/d of the test substance.

After application neither deaths nor clinical symptoms occurred. Development of body weight was not impaired. The animals were killed at the end of the observation period of 14 days and showed no macroscopically visible changes.

Acute oral toxicity testing to B-TEGME in the Wistar rat yielded a median lethal dose level above 2000 mg/kg body weight in both male and female animals.