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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:
1969 (march 14-19, and may 13-30)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles; pre-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
20 animals/dose
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3-6-Trimethyl-phenol (TMP)
Analytical purity: 99%

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals and environmental conditions:
day /night rhythmus 12/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous Traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2, 16, and 30% (w/v)
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: no data

No further data.
Doses:
200, 1600, 3200, 3600, 4000, 5000, 6400 mg/kg bw
No. of animals per sex per dose:
20 animals per dose (10/sex)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily (observations); body weight males: 215-250g, female 174-200g
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 600 mg/kg bw
Remarks on result:
other: after 7 days; 95% CL not given
Mortality:
Deaths occurred at all dose levels with exception of the lowest dose (200 mg/kg bw); see table below.
Clinical signs:
6400-1600 mg/kg bw:
Squatting posture or prone/lateral position (immediately after dosing), calm behaviour, accelerated or superficial respiration, piloerection, moderate secretion of the buccal cavity, masticatory movements, extended hind limbs, apathy, and weak tonus were observed in these groups.
At 5000 and 4000 mg/kg bw, narcosis was observed after approximately 15 minutes. At the day after dosing, surviving animals of these two dose groups exhibited intermittent respiration and piloerection.
The remaining animals were normal by days 3-4.

200 mg/kg bw:
No clinical symptoms were observed.
Body weight:
no data
Gross pathology:
Decedents:
hydrothorax (17 rats)
serous adhesions at the snout (14 rats)
plethora and serosa of the pleura (21 rats)
deposits of the test material in the stomach (2 rats)

Survivors: no pathological changes of the organs

Any other information on results incl. tables

Mortality rates after 1, 24, and 48 hours and after 7 days

Dose [mg/kg] conc. [%]  no. of rats 1 h 24 h 48 h 7 d
6400 30 20 0/20 19/20 19/20 19/20
5000 30 20 0/20 20/20 20/20 20/20
4000 30 20 0/20 15/20 16/20 16/20
3600 30 20 0/20 7/20 9/20  9/20
3200 30 20 0/20 6/20 6/20 6/20
1600 16 20  0/20 3/20 3/20 3/20
200 2 20 0/20 0/20 0/20 0/20

Applicant's summary and conclusion

Executive summary:

10 male and 10 female rats were administered the test substance orally and were observed for 7 days. The acute oral LD50 was 3600 mg/kg bw for both males and females.