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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,3,6-tetrahydrophthalic anhydride
EC Number:
201-605-4
EC Name:
1,2,3,6-tetrahydrophthalic anhydride
Cas Number:
85-43-8
Molecular formula:
C8H8O3
IUPAC Name:
1,3,3a,4,7,7a-hexahydro-2-benzofuran-1,3-dione
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 or test system 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:
other: at toxic doses: Dyspnoea; abdominal position, staggering
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