Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Isooctyl acrylate
EC Number:
249-707-8
EC Name:
Isooctyl acrylate
Cas Number:
29590-42-9
Molecular formula:
C11H20O2
IUPAC Name:
6-methylheptyl acrylate
Constituent 2
Reference substance name:
T-2110
IUPAC Name:
T-2110
Details on test material:
- Name of test material (as cited in study report: T-2110
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, MichiganI
- Weight at study initiation: Males 277 grams (average), Females 237 (average)
- Fasting period before study: Yes, food only withheld overnight before study
- Diet (e.g. ad libitum): Rodent Chow 5001, Purina Mills, Inc., ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS - All housing conditions in accordance with those outlined in the Guide for Care and Use of Animals
- Temperature (°C): 18-23 C
- Humidity (%): 19%-39% humidity-
IN-LIFE DATES: From: 10/19/88To: 11/02/88

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5.0 g/kg body weight
No. of animals per sex per dose:
5 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: Observed at 1, 2.5, 4 hours after dosing, and daily thereafter; weighed at pre-dose, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No treatment related mortality was observed.
Clinical signs:
Signs related to GI irritation and CNS depression were observed during the study
Body weight:
Average body weights for males increased 13%, females increased 43%
Gross pathology:
No treatment related effects were noted.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Rat Oral LD50 >5000 mg/kg/bw
Executive summary:

Five male and five female rats were administered undiluted test material at 5.0 g/kg via oral gavage. The animals were observed for clinical signs and mortality for 14 days after dosing. After this period, the animals were sacrificed, weighed and evaluated for gross lesions. No treatment-related deaths were noted. Average body weights for male and female rats increased 43% and 13%, respectively. Clinical signs consistent with GI irritation (diarrhea) and mild CNS depression (ataxia and hypoactivity) were observed. No significant gross lesions were noted at necropsy. The rat oral LD50 was concluded to exceed 5000 mg/kg body weight.