Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test compound in report: CESIO 19
Name of test compound: alkylamine ethoxylates, hydrogenated tallow 2EO
Appearance: off-white waxy solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
All animals showed hunched posture and pilo-erection 1 and 4 h after treatment.
Body weight:
Surviving animals (7/9) showed expected bw gains. One female (1/9) showed reduced bw gain at the end of the 2nd week,
another female (1/9) showed slight bw loss at that time.
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).