2,2'-(C16-18 (evennumbered) alkyl imino) diethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Substance: CESIO 19. No data on batch no. and composition. Basic data given; comparable to guidelines/standards. No information on concentration/dose volume

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

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:

2,2'-(C16-18 (evennumbered) alkyl imino) diethanol

EC Number:

620-539-0

Cas Number:

1218787-30-4

Molecular formula:

No molecular formula

IUPAC Name:

2,2'-(C16-18 (evennumbered) alkyl imino) diethanol

Test material form:

other: waxy solid

Details on test material:

- Chemical name: 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- EC number: 620-539-0

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Natin & Kingman Ltd., Grimston, Hull, UK
- Age at study initiation: ca. 5-8 weeks
- Weight at study initiation: 120-132 g (males), 122-136 g (females)
- Fasting period before study: overnight prior to dosing until 2-3.5 h after dosing
- Housing: 5/sex in solid floor propylene cages with sawdust bedding
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: methylcellulose (1%)

Details on oral exposure:

VEHICLE
- 1% methylcellulose
- Concentration in vehicle: not indicated
- Amount of vehicle (if gavage): not indicated
- Justification for choice of vehicle: not indicated

MAXIMUM DOSE VOLUME APPLIED: not indicated, based on fasted bw at the time of dosing

Doses:

25, 200, 2000, 5000 mg/kg bw (range-finding study)
2000 mg/kg bw (main study)

No. of animals per sex per dose:

1/sex (range-finding study): 8 in total
5/sex (main study): 10 in total

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (5 days in rang-finding study)
- Frequency of observations and weighing: 1 and 4 h after dosing, once daily therafter. BW weekly
- Necropsy of survivors performed: yes (not on animals of the range-finding study)

Statistics:

Not required.

Results and discussion

Preliminary study:

1 out of 2 animals died at 5000 mg/kg bw (range-finding study); therefore 2000 mg/kg bw was chosen as target level in main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 1/5 females was found dead

Mortality:

One female was found dead 2 days after treatment.

Clinical signs:

other: All animals showed hunched posture and pilo-erection 1 and 4 h after treatment.

Gross pathology:

Necropsy findings in the deceased animal consisted of abnormally red lungs, dark liver and kidneys and haemorrhage of the gastric mucosa. No abnormalities were noted in survivors.

Other findings:

No.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The oral LD50 is larger than 2000 mg/kg bw. However, based on 10% mortality at this level and 1/2 rats dying at 5000 mg/kg bw
(range-finding study), the LD50 is expected to be close to 5000 mg/kg bw. Therefore classification in Category V, according to
OECD-GHS criteria.

Executive summary:

The study was performed to assess the acute toxicity of the test material following a single oral administration to the Sprague-Dawley strain rat. The study was performed according to OECD guideline 401. Following a range-finding study, a group of ten fasted animals (five male and five female) was given a single, oral dose of the test material at a dose level 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of dosing and were then killed for gross pathological examination. One female was found dead 2 days after dosing. Clinical signs of toxicity noted were hunched posture and pilo-erection 1 and 4 h after dosing. Most survivors showed expected gains in bodyweight over the study period; in 2 female rats bw gain was reduced or slight body weight loss was observed. No abnormalities were noted in survivors at necropsy; the deceased animal showed abnormally red lungs, dark liver and kidneys and haemorrhage of the gastric mucosa. The acute median lethal dose (LD50) of the test material was found to be greater than 2000 mg/kg bodyweight. The test material was considered not to have significant acute toxicity and does require classification in Category V, according to OECD-GHS (based on 10% mortality at 2000 mg/kg bw and 1/2 dead animals at 5000 mg/kg bw).