Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1984

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Hydrogenated tallow alkyl amin
IUPAC Name:
Hydrogenated tallow alkyl amin
Constituent 2
Reference substance name:
Amines, hydrogenated tallow alkyl
EC Number:
262-976-6
EC Name:
Amines, hydrogenated tallow alkyl
Cas Number:
61788-45-2
IUPAC Name:
61788-45-2
Details on test material:
- Name of test material (as cited in study report): Lilamin AC-HBG/P

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Pemberley Rabbits, Cottenham, Cambridgeshire
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 2.0 to 2.2 kg
- Housing: individual housing in metal cages
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 19
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 19
- Photoperiod (hrs dark / hrs light): 12/12 (19:00-7:00 / 7:00-19:00)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % (w/v) suspension in 1% methyl cellulose

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:
5000 mg/kg body weight
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: clinical observations daily; weighing on day 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities throughout study
Clinical signs:
Pilo-erection, hunched posture, diarrhoea
Body weight:
slightly reduced on day 8 but normal by day 15
Gross pathology:
no abnormal findings
Other findings:
no abnormal findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings of this limit test, the acute median lethal dose (LD 50) of Lilamin AC-HBG/P after a single dose to rats was greater than 5000 mg/kg body weight
Executive summary:

In an GLP compliant OECD TG 401 study, the test material Lilamin AC-HBG-P (hydrogenated tallow alkyl amine), a white granular solid (purity 95%), was orally applied to Wistar rats at a dose of 5000 mg/kg bw. The substance was applied as a 50% suspension in 1% methylcellulose (limit-test). There were no deaths, hence, the LD50 exceeded 5000 mg/kg. Clinical signs were diarrhea, piloerection, hunched posture, abnormal gait and pallor of extremities. Complete recovery from these clinical signs was observed by day 5. Body weights were initially reduced but body weight gain was not different from controls by the end of the study (day 15). No treatment-related effects were observed at necropsy. Based on the findings of this study, the acute median lethal dose (LD 50)