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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets basic scientific principles; comparable to guideline study; basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; 10 animals per dose level, no pathology, only one sex tested, limited reporting
GLP compliance:
no
Remarks:
pre-GLP stuidy
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sun oil X489-17B
- no further information

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 24 h
- Animals were fed, housed and watered in accordance with standard laboratory procedures.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
1, 3, 5, 8, 10, and 15 g/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 1, 3, 6, 24, 48, 72 h, and daily thereafter; no information on weighing
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
LD 50 was determined in accordance with the method of Miller and Tainter (Proc. Soc. Exp. Biol. Med. NY , 57, 261-264, 1944)

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 650 mg/kg bw
Based on:
test mat.
Remarks on result:
other: S.E. = 640 mg/kg bw
Clinical signs:
Decreased locomotor activity, piloerection, ataxia, ptosis.
In the lowest dose group, slight systemic toxicity prevalently related to CNS effects (decreased locomotor activity) was observed. 4 days after treatment, the test animals appeared normal again. Severity of clinical signs increased with dose.
Body weight:
no data
Gross pathology:
no data
Other findings:
--

Any other information on results incl. tables

Mortality

 

Dose
[g/kg bw]

Animals per Group

Day

Total

2

3

4

1

10

0

0

0

0/10

3

10

0

1

1

2/10

5

10

0

4

2

6/10

8

10

2

5

1

8/10

10

10

3

3

2

8/10

15

10

0

3

7

10/10

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Monoisopropylbiphenyl is only slightly acute toxic. LD50 was determined to be 4650 mg/kg bw. Classification according EU regulations is not required.