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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Isotridecanol, ethoxylated
EC Number:
500-241-6
EC Name:
Isotridecanol, ethoxylated
Cas Number:
69011-36-5
Molecular formula:
not available, isomeric structures
IUPAC Name:
Isotridecanol, ethoxylated

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: No data
- Weight (mean) at study initiation: 108.7 g
- Fasting period before study: yes (at least 16 hours before administration)
- Housing: 1-5 animals in Makrolon Type III cages
- Diet: R10 Alleindiät für Ratten (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10.5 mL/kg
Doses:
10,000 mg/kg
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:
Body weight determination: Individual body weights on Day 1, 7 and 14.
Symptoms/Mortality: Recording of symptoms several times on the day of administration, thereafter daily.
- Necropsy of survivors performed: yes (Necropsy with gross-pathology examination on the last day of the observation period.)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.

Clinical signs:
other: 1 h after application all animals showed piloerection and some additionally diarrhoea. Later on the clinical signs comprised hunched posture, slowed movement, slight to moderate sedation and ataxia, staggering gait, temporarily ventral position, tremor, c
Gross pathology:
At necropsy all animals showed thickening of the glandular stomach mucosa.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.