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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
10 Sep 1991 - 24 Sep 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Cetyl-2-Ethylhexanoate. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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)
Deviations:
no
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 material (as cited in study report): Only trade name given
- Chemical denomination: Cetyl-2-Ethylhexanoate
- Batch No.: Lot 120300
- Delivery: August 20, 1991
- Physical state: colourless liquid
- Analytical purity: 100 %
- Stability Pure: stable for at least two years
- Stability in Solvent: stable in Arachis oil
- Expiration date: December 31, 1993

Test animals

Species:
rat
Strain:
other: rat, Bor: WISW (SPF) Cpb
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: mean 174 g (males), 165 g (females)
- Fasting period before study: 16 hours
- Housing: groups of 5 animals in Makrolon Type-3 cages with standard softwood bedding
- Diet: pelleted Altromin Maintenance Diet 1324, Altromin GmbH, Lage, Germany , ad libitum
- Water: tap water , ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 60
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Purity: DAB 9

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
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: several times on the application day and twice daily thereafter.
- Frequency of weighing: one day before application, on the day of application, on days 2, 7 and 14.
- Necropsy of survivors performed: yes, external examination and thoracal and abdominal cavities.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rats
Mortality:
No deaths occurred.
Clinical signs:
No signs of systemic toxicity were observed.
Body weight:
All animals showed the expected gain in body weight.
Gross pathology:
No treatment- related findings.

Any other information on results incl. tables

Mean body weights (g):

Day

Male

Female

-1

182

173

day of application

174

165

2 d

192

178

7 d

224

179

14 d

260

190

Body weight gain

78

17

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified