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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From February 20, 1996 to April 4, 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD Guideline 401 (Acute Oral Toxicity) and EU Method B1 and in compliance with GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Amidet A-111
- Physical state: Cream coloured flakes
- Lot/batch No.: 2020430
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 5-8 wk
- Weight at study initiation: Males - 152 - 182 g, females - 140-156 g
- Fasting period before study: Overnight
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: Rat and mouse expanded diet no. 1, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 44-65
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg




Doses:
2,000 mg/kg in both range-finding and main study
No. of animals per sex per dose:
one in range-finding study and five in main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of clinical observation: 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 d
- Frequency of weighing: On Day 0, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination
Statistics:
None

Results and discussion

Preliminary study:
No deaths or clinical signs of toxicity
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: None
Mortality:
No mortality
Clinical signs:
No signs of systemic toxicity
Body weight:
All animals showed an expected gain in body weight except one female which showed reduced body weight gain during the second week of observation

Gross pathology:
No abnormalities noted at necropsy
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the LD50 of amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) in the Sprague-Dawley CD rat was found to be greater than 2,000 mg/kg.
Executive summary:

An OECD guideline 401 and EU Method B1 study was performed to assess the acute oral toxicity of amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) in Sprague-Dawley CD rat.

Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test material as a solution in arachis oil BP at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. There were no mortalities in the study. No signs of systemic toxicity were noted during the study. All animals showed an expected gain in body weight during the study except one female which showed reduced body weight gain during the second week. No abnormalities were noted at necropsy.

Under the test conditions, the LD50 of amides, C8-18 and C18-unsatd., N-(hydroxyethyl) in Sprague-Dawley CD rat was found to be greater than 2,000 mg/kg.