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Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
Use of 2000 mg/kg bw as limit dose. Use of 2 animals per sex.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 and C18-unsatd., isooctyl esters, epoxidized
EC Number:
307-159-8
EC Name:
Fatty acids, C16-18 and C18-unsatd., isooctyl esters, epoxidized
Cas Number:
97553-05-4
Molecular formula:
Unspecified
IUPAC Name:
Fatty acids, C16-18 (even numbered, C18 unsaturated), isooctyl esters, epoxidized
Test material form:
liquid
Specific details on test material used for the study:
- in the study report the old CAS 68082-34-8 number is given
- Name of test material (as cited in study report): Edenol B35 (neu)
- Chemical name: 2-Ethylhexyl-Epoxystearate
- Physical state: liquid, light yellow
- Analytical purity: 100%
- Lot/batch No.: 273

Test animals

Species:
rat
Strain:
Wistar
Remarks:
TNO
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen (district Paderborn)
- Age at study initiation: 152 g (females), 174 g (males)
- Weight at study initiation: at least 6 weeks
- Fasting period before study: 15 hours before treatment until 3 hours post-treatment
- Housing: 2 rats per Makrolon cage (type III)
- Diet: Altromin 1324 pellets, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50-70
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED:
10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations for mortality and symptoms: Several times at the day of application, twice daily afterwards.
- Frequency of weighing: Day -1 before fasting, day of application as well as 48 hours, 1 week, and 2 weeks after application.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Directly after application: piloerection, lethargy
Day 2-3: lethargy
Body weight:
For details see table 1 "Any other informations on results".
Gross pathology:
No findings.

Any other information on results incl. tables

Table 1: Development of body weights of rats during the acute oral toxicity study.

Animal No.

Sex

Day -1

Day of application

Day 2

Day 7

Day 14

1

Male

182

173

184

203

236

2

Male

190

175

186

208

228

1

Female

155

149

157

164

166

2

Female

164

154

160

156

169

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality occurred and no gross pathology findings were observed.
Executive summary:

In an acute oral toxicity study equivalent to OECD TG 401 (adopted 1981, no GLP), the test substance was administered by oral gavage to two Wistar rats of each sex at 2000 mg/kg bw as a limit dose. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 15 days. Clinical signs of toxicity, body weights as well as gross pathological findings were recorded. Directly after application piloerection and lethargy were observed as clinical signs. Lethargy was present at day 2 and 3 after administration. No animals died on account of the treatment nor did they show severe signs of toxicosis in the 14 observation period. The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg bw.