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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:
July - September 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study in accordance with methods regarded as similar/equivalent to current OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Study pre-dates introduction of OECD test methods. Study design similar/equivalent to OECD test methods
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
EC Number:
246-644-8
EC Name:
1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
Cas Number:
25134-21-8
Molecular formula:
C10H10O3
IUPAC Name:
3a,4,7,7a-tetrahydromethyl-4,7-methano-2-benzofuran-1,3-dione
Details on test material:
- Name of test material (as cited in study report): Methyl endo-methylene tetrahydro phthalaic anhydride (MHAC-P)
- Physical state: Liquid
- Lot/batch No.: 6953

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 99 - 133 g
- Fasting period before study: Overnight
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

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

IN-LIFE DATES: From: July 1980 To: September 1980

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 4.0mL/kg body weight
Doses:
0.0, 0.5, 1.0, 1.6, 2.5, 5.0 g/kg body weight
No. of animals per sex per dose:
5 male / 5 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed daily, weighed weekly
- Necropsy of survivors performed: yes
Statistics:
Probit analysis by method of Finney

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 300 mg/kg bw
Based on:
test mat.
95% CL:
1 100 - 1 600
Mortality:
0.0 g/kg - 0/5 males: 0/5 females
0.5 g/kg - 0/5 males: 0/5 females
1.0 g/kg - 1/5 males: 0/5 females
1.6 g/kg - 3/5 males: 5/5 females
2.5 g/kg - 5/5 males: 5/5 females
5.0 g/kg - 5/5 males: 5/5 females
Clinical signs:
other: Signs of reaction to treatment, observed shortly after dosing in all treated animals included piloerection, abnormal body carriage (hunched posture) and abnormal gait (waddling). These were accompanied by: lethargy, a decreased respiratory rate, pallor of
Gross pathology:
Autopsy revealed congestion and haemorrhages in the lungs and pallor of the liver, spleen and kidneys. These findings were accompanied by: congestion of the intestinal blood vessels amongst rats treated at 1.6 g/kg and above; a creamy-coloured film on the liver in one male and female treated at 2.5 g/kg and three males and females at 5.0 g/kg; haemorrhage of the large intestine and discolouration of its contents in one male treated at 5.0 g/kg; discolouration of the large intestinal contents in one female treated at 5.0 g/kg. Terminal autopsy findings (those animals surviving treatment) were within normal limits.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute toxicity has been determined in the rat following administration of a single oral dose. The median lethal dose (LD50) was determined to be 1300 mg/kg body weight.
Executive summary:

Acute toxicity has been determined in the rat following administration of a single oral dose using method regarded a similar or equivalent to OECD test methods. The median lethal dose (LD50) was determined to be 1300 mg/kg body weight.