Amines, C36-alkylenedi-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting 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

Test material information

Constituent 1

Reference substance name:

Hydrogenated Tallow Alkylamins

IUPAC Name:

Hydrogenated Tallow Alkylamins

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

Constituent 3

Reference substance name:

Amines, tallow alkyl

EC Number:

263-125-1

EC Name:

Amines, tallow alkyl

IUPAC Name:

263-125-1

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:

other: Pilo-erection, hunched posture, diarrhoea

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 Hydrogenated tallow alkyl amine 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 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) of Hydrogenated tallow alkyl amine after a single dose to rats was greater than 5000 mg/kg body weight.