1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride

Acute Toxicity: oral

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

Test material information

Constituent 1

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.