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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 11, 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 B.1 and in compliance with GLP
Justification for data waiving:
other:
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 B-112
- Physical state: Pale straw coloured viscous liquid
- Lot/batch No.: 954130
- 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: 152-174 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 (%): 39-65
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 1.99 mL/kg





Doses:
2,000 mg/kg
No. of animals per sex per dose:
Five
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 Days 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 expected gain in body weight

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 and C18-unsatd., N,N-bis(hydroxyethyl) in the Sprague-Dawley CD rat was found to be greater than 2,000 mg/kg.
Executive summary:

A study was performed to assess the acute oral toxicity of amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) in the Sprague-Dawley CD rat according to OECD Guideline 401and EU Method B.1.

A group of 10 fasted animals (five males and five females) was administered a single oral dose of undiluted test material at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then sacrificed and subjected to gross pathological examination.

No mortalities were observed in the study. No signs of systemic toxicity were noted during the study. All animals showed expected gain in body weight during the study. No abnormalities were observed at necropsy.

 

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