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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. Only limited information on the test material is available. No analytical purity of the test substance is given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-2-hydroxyethyllactamide
EC Number:
226-546-1
EC Name:
N-2-hydroxyethyllactamide
Cas Number:
5422-34-4
Molecular formula:
C5H11NO3
IUPAC Name:
N-2-hydroxyethyllactamide

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A. Smith, Warlingham, Surrey, UK
- Age at study initiation: young adults
- Weight at study initiation: 160 – 186 g (males), 165 – 186 g (females)
- Fasting period before study: animals were fasted overnight prior to dosing
- Housing: animals were housed in single sex groups of five in grid bottomed polypropylene cages
- Diet: pelleted rodent diet (modified 41B, Pilsbury´s Limited of Birmingham), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 24
- Humidity (%): 56 – 74
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution of tragacanth gum
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5000 mg/kg bw
- Amount of vehicle: 10 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION
The test material was suspended in a 0.25% aqueous solution of gum tragacanth to give a dose volume of 10 mL/kg at a dose level of 5000 mg/kg bw.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were examined macroscopically including the opening of the cranial, thoracic and visceral cavities.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortalities or clinical signs of toxicity observed
Mortality:
No mortalities were observed during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed during the study period.
Gross pathology:
No abnormalities were recored at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified