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Diss Factsheets

Administrative data

Description of key information

A study was carried out equivalent or similar to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity). The acute oral median lethal dose (LD50) of the test item in the rat was found to be: 
- both sexes: 1110 mg/kg
- males: 979 mg/kg
- females: 1281 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species, strain and supplier:
Twenty-four male and 24 female Wistar-derived rats of the Crl :(WI)BR strain obtained from Charles River (UK) Ltd., Manston Road, Margate, Kent, were used for the study.

Specification:
On the day before treatment the body weights of the animals used in the definitive study were between 143 and 205 g. The animals were aged between 6 and 10 weeks and were acclimatised to the laboratory environment for 5 days. Before starting the study all animals were examined for signs of ill health or injury. All animals appeared healthy and no animals were discarded.

Husbandry:
The animals were housed in a single air-conditioned room maintained at a temperature and relative humidity of 17 to 21°C and 44 to 65% respectively. Fluorescent lighting was automatically controlled to give a cycle of 12 hours light (06.00 to 18.00 hr) and 12 hours darkness. Environmental conditions were recorded twice daily on weekdays and once daily at week-ends.
Animals were caged in groups of 4 by sex for the screening study and in groups of 5 by sex and dose group for the definitive study. The solid floor polypropylene cages were provided with a bedding of softwood sawdust (Sawdust Marketing Company Ltd., Standon, Herts.) which was replaced twice each week.

Diet and drinking water:
With the exception of an overnight fast before dosing the animals were allowed free access to food (SQC Rat and Mouse Maintenance Diet No. 1, Expanded, Special Diets Services Ltd., Stepfield, Witham, Essex). Mains water was provided at all times and dispensed from glass water bottles. The diet and drinking water were considered not to contain any contaminant at a level that might have affected the purpose or integrity of the study. The food was reintroduced immediately after treatment.
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
A pretest with four groups, each of 2 fasted rats (1 male, 1 female), was performed to determine the appropriate dose levels for the main study. In this screening test, doses of 50, 250, 1250 and 5000 mg/kg were applied.
Doses:
In the definitive study, dose levels were 707, 1000, 1410 and 2000 mg/kg.
No. of animals per sex per dose:
5 males and 5 females per dose level
Control animals:
no
Preliminary study:
The mortalities observed in the pretest indicated an oral LD50 was approximately1250 mg/kg.
Sex:
male
Dose descriptor:
LD50
Effect level:
979 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No fiducial limits possible
Sex:
female
Dose descriptor:
LD50
Effect level:
1 281 mg/kg bw
Based on:
test mat.
95% CL:
849 - 2 244
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 110 mg/kg bw
Based on:
test mat.
95% CL:
908 - 1 336
Mortality:
A total of 22 (13 male, 9 female) of the 40 animals died during the study period. All deaths were noted between 3 and 8 days after treatment (see also clinical signs).
Clinical signs:
other: One female animal treated with 707 mg/kg showed piloerection and lethargy 15 minutes and 1 hour after dosing. With the exception of the female animal that was found dead on day 4 all animals appeared normal throughout the observation period. No treatment-
Gross pathology:
Major pathological findings in animals dying during the study were associated with the liver. This organ showed abnormal appearance and was pale in colour with light patches on all lobes.
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the rat was:
- both sexes: 1110 mg/kg
- males: 979 mg/kg
- females: 1281 mg/kg
Executive summary:

A study was carried out equivalent or similar to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity). Following a screening study (one male & one female at doses of 50, 250, 1250 and 5000 mg/kg, 4 groups, each of 10 fasted rats (5 male, 5 female) were treated with a single oral dose of P5240 at dose levels between 707 and 2000 mg/kg. Vehicle was corn oil, application by gavage.

A total of 22 (13 male, 9 female) of the 40 animals died during the study period at highe dose groups. All deaths were noted between 3 and 8 days after treatment. High dose animals showed a number of clinical signs such as piloerection, lethargy, hunched posture, emaciation etc. All surviving animals showed body weight gains at the end of the study period. Major pathological findings in animals dying during the study were associated with the liver. In conclusion, the acute oral LD50 was determined to be 979 mg/kg for male rats, 1281 mg/kg for female rats and 1110 mg/kg for both sexes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
979 mg/kg bw
Quality of whole database:
Guideline study; Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The GHS criteria for classifying a substance as Category 4 acute toxicity hazard is triggered when the acute toxicity estimate is between 300 and 2000 mg/kg body weight. Since the lowest LD50 is 979 mg/kg body weight, the test material is within range for classification as a Category 4 acute toxicity hazard (H302 - Harmful if swallowed).