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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: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
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):Tetrahydrophthalsäure-anhydrid (Tetra hydro phthalic acid anhydride)
- Physical state: solid
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 233 +/-34.7 g (male); 203 +/- 38.7 (female)
- Fasting period before study: not reported, probably overnight before dosing
- Housing: groups
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous suspension of 1% Traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2% ,16% and 20 % w/Vol.
- Justification for choice of vehicle: not given probably solubility

MAXIMUM DOSE VOLUME APPLIED: 6.9 mL
Doses:
200, 1600, 3200, 6400 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days (not supposed to have an influence on the result)
- Frequency of observations and weighing: only at study initiation for dose calculation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 200 mg/kg bw
Based on:
test mat.
Mortality:
200 mg/kg : 0/10
1600 mg/kg: 0/9
3200 mg/kg 5/10
6400 mg/kg 10/10
Clinical signs:
at toxic doses: Dyspnoea; abdominal position, staggering
Body weight:
not recorded
Gross pathology:
animal sacrificed at study termination: nothing abnormal detected
animals that died: gastro intestinal irritation; corrosive effects

Applicant's summary and conclusion

Conclusions:
The LD50 following administration of a single oral dose to rats was approximately 3200 mg/kg body weight
Executive summary:

Acute oral toxicity has been investigated using methods similar to those described in OECD/EU test guidelines. The LD50 following administration of a single oral dose to rats was approximately 3200 mg/kg body weight