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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:
June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
- Name of test material (as cited in study report): Cosmacol ECL
- Substance type: pure active substance
- Physical state: solid (white flakes)
- Lot: 140512
- SID: 54844

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Morino - S. Polo d'Enza (RE), italy
- Age at study initiation: not mentioned
- Weight at study initiation: 220 - 310 g (males: 308 ± 34.1 g, females: 237 ± 12.6 g)
- Fasting period before study: not mentioned
- Housing: in groups of five of the same gender in transparent polycarbonate cages (dimensions 425x266x180 mm)
- Diet: standard pellet complete diet ad libitum
- Water: filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-06-02 To: 1992-06-16

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/ml
- Justification for choice of vehicle: sesame seed oil is non-toxic to used species
- Purity: not mentioned

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg b.w.
Doses:
5000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (5 days out of 7)
- Frequency of observations and weighing: daily observations of mortality, organic body functions, tegumentary apparatus, mucosae conditions, somamotor activity and sensorium conditions, weighing before the experiment, after 7 days and at the end of the study
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clincial symptoms were observed related to treatment.
Body weight:
Body weight gain was normal for the species and strain used in the study.
Gross pathology:
At the ante-mortem and post-mortem the animals showed no pathologic symptoms. Nothing abnormal was found in the autopsy on animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In these experimental conditions the test material 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15) ester did not provoke toxic effects. The LD 50 was greater than 5000 mg/kg body weight.
Executive summary:

An acute oral toxicity test was carried out on a group of 10 rats (5 male and 5 female) using 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15) ester. The test material was administered at a dose of 5000 mg/kg oral by gavage. During the study the animals were observed daily for 14 days (5 out of 7) for signs of possible toxic symptoms and mortality. Body weight was noted weekly. At the end of the study necropsy was performed on all animals.

None of the animals died during the course of the study, no clincial samptoms were observed that could be related to treatment, the body weight gain was normal for the species and strain. At necropsy the animals showed no pathological symptoms or abnormalities ante- and post-mortem.

The test material Cosmacol ECL did not provoke toxic effects under the experimental conditions described and the LD50 was judged to be greater than 5000 mg/kg b.w.