Amines, C16-18 and C18-unsatd. alkyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-02-08 to 1988-03-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, tallow alkyl

EC Number:

263-125-1

EC Name:

Amines, tallow alkyl

Cas Number:

61790-33-8

IUPAC Name:

61790-33-8

Constituent 2

Reference substance name:

Tallow Alkylamines

IUPAC Name:

Tallow Alkylamines

Details on test material:

- Name of test material (as cited in study report): Genamin TA 100 D

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Strain: Hoe: WISKf(SPF71)
- Age at study initiation:
- male ca. 7 weeks
- female ca. 8weeks
- Weight at study initiation:
- male mean = 176 g; min = 167 g, max = 189 g; sd = +-8g
- female mean = 175 g; min = 171 g, max = 181 g; sd = +-4g
- Randomized
- Fasting period before study: 16 h before application and 3-4 hours after application of the test substance
- Housing: fully air-conditioned in makrolon cages (type 4) on soft wood chips in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 (Altromin-GmbH, Lage/Lippe) ad libitum
- Water (e.g. ad libitum): tap-water ad libitum
- Acclimation period: min 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 50 +- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

TEST ANIMALS
- Source: Hoe: WISKf (SPF71), Hoechst AG, Germany
- Age at study initiation: ca. 7 weeks (male animales); ca. 8 weeks (female animals)
- Weight at study initiation: 176g +/- 8g (male animals); 175g +/- 4g (female animals)
- Fasting period before study: ca. 16 hours prior and 4 hours after application
- Housing: Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- Concentration in vehicle: 20%, 25% (w/v)

Doses:

2000 mg/kg body weight (male and female animals)
2500 mg/kg body weight (male animals only)

No. of animals per sex per dose:

5 male and 5 female (2000 mg/kg bw)
5 male (2500 mg/kg bw)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations once daily / Weighing once weekly
- Necropsy of survivors performed: yes
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no

Statistics:

Probit analysis

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

0 out of 5 female animals at 2000 mg/kg body weight
1 out of 5 male animals at 2000 mg/kg body weight
1 out of 5 male animals at 2500 mg/kg body weight

Gross pathology:

Dissection of the two male rats that died during the course of the study revealed bright scattered coloration of the liver and lungs. The gastrointestinal tract was filled with gas. The rats that were killed at the end of the observation period were free of macroscopic findings.

see annex 6.3 of attached study report for additional details

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, Genamin TA 100 D is not subject to labelling and classification requirements according to directive EC 1272/2008 with regard to acute oral toxicity

Executive summary:

The acute oral toxicity of Genamin TA 100 D was investigated in rats using sesam oil as vehicle. 5 male and 5 female rats were administered the test compound by single-dose gavage at a dose levels of 2000 mg/kg body weight. A separate group of 5 male rats received an additional dose of 2500 mg/kg body weight by gavage. The observation period was 14 days. After administration of 2000 and 2500 mg/kg body weight one male animal died whereas all female animals survived treatment with 2000 mg/kg body weight. Both fatal intoxicated animals showed the following symptoms: bristled coat, squatting posture, stilted gait, irregular respiration and decreased spontaneous activity. At necropsy the following findings were revealed: Gastrointestinal tract filled with gas, bright scattered coloration of lung and liver. No clinical symptoms were observed at the end of the observation period. Based on the findings of this test the median lethal dosage (LD50) of Genamin TA 100 D in the male and female rat is greater 2000 mg/kg body weight.