Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 April 1997 - 12 June 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

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
Test material form:
liquid: viscous
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ExxonMobil Chemical Company (Edison, NJ) Lot# C96302.01,2
- Expiration date of the lot/batch: 31 October 2001
- Purity test date: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable through duration of test
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc. (Portage, MI; Hollister, CA)
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 6 to 12 weeks of age
- Weight at study initiation: 224 to 261 g
- Fasting period before study: 17 to 20 hours
- Housing: Animals were separated by sex and group housed in suspended screen-bottom stainless steel cages.
- Diet (e.g. ad libitum): Laboratory Rodent Diet #5001 (PMI Foods Inc.)
- Water (e.g. ad libitum): water periodically analyzed for contaminants
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 50% ± 20%
- Air changes (per hr): not spepcified
- Photoperiod (hrs dark / hrs light): 12 hour dark/light

IN-LIFE DATES: From: 16 April 1997 To: 30 April 1997

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
An individual dose of the undiluted test material was calculated for each animal based on its fasted body weight and administered as a single gavage dose. The test material was administered at a volume of 2.04 mL/kg of body weight based on an average bulk density of 0.98 g/mL.
Doses:
2.0 g/kg
No. of animals per sex per dose:
5 males; 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality checks were conducted twice a day (morning and afternoon) for 13 days after test material administration and again the morning of Day 14. Body weights were determined before test material adminstration (Day 0) at Day 7, and at termination of the in-life phase (Day 14).
Statistics:
No statistical analyses were required by the protocol

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the study.
Clinical signs:
One male animal appeared normal throughout the entire study. All other animals exhibited a red-stained face within 2.5 hours after test material administration. Two of five females were noted with a wet urogenital area on the day of treatment. All animals returned to a normal appearance by Day 2 after treatment.
Body weight:
All animals exhibited body weight gain throughout the study.
Gross pathology:
No lesions were observed at the gross necropsy examination.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone following oral intubation was established at >2000 mg/kg for males and females. This finding does not warrant classification of Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone as an acute oral toxicant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Executive summary:

Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone was administered via oral intubation to 5 female and 5 male Crl:CD(SD) rats at 2.0 g/kg to assess the acute oral toxicity. Animals were observed daily for 14 days post dosing. No overt signs of toxicity were apparent and mortality was not observed at the dose level tested; all animals were free of abnormalities at postmortem examination. All animals displayed increases in body weight over their day 0 values. The LD50 for Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone based on these data was established at >2000 mg/kg for males and females. This finding does not warrant classification of Hydrazine Carboximidamide, 2-((2-hydroxyphenyl)methylene)-, reaction products with 2 undecanone as an acute oral toxicant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).