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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

1
Chemical structure
Reference substance name:
1,5-Diisocyanatopentane
EC Number:
807-040-5
Cas Number:
4538-42-5
Molecular formula:
C7H10N2O2
IUPAC Name:
1,5-Diisocyanatopentane
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Orient Bio Co., Ltd. 8, Hwaaksan-ro 124beon-gil, Buk-myeon, Gapyeong-gun, Gyeonggi-do, Korea

- Age at study initiation: approx. 9 weeks
- Weight at study initiation: 200-211 g
- Housing: less than 3 animals per cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 6 days Quarantine and acclimatization periods

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C 20.6-23.6
- Humidity (%): 55 ± 10 °C 49.8-62.0
- Photoperiod (hrs dark / hrs light): 12h rhythm

IN-LIFE DATES: From: 22 January 2019 To: 28 February 2019

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Test substance was formulated with vehicle at 30 mg/mL (1st step), 5 mg/mL (2nd, 3rd step) concentration. The administration volume was 10 mL/kg b.w. The formulated test substance was not analysed for concentration, stability and homogeneity.
Doses:
300 mg/kg and 50 mg/kg
No. of animals per sex per dose:
3 (300 mg/kg) and 6 (2x 3 at 50 mg/kg)
Control animals:
no
Details on study design:
Clinical signs were carefully observed for 0.5, 1, 2, 3 and 4 hours after administration and then once each day for 14 days.
Body weights were measured at animal receipt day, animal allocation day, just before treatment and on day 1, 3, 7 and 14 after the administration, found death animal.
At the end of observation period and death animal, external observations were conducted and sacrificed by blood letting under anesthesia for all survived animals.Then the organs were examine for gross lesions.

Statistics:
No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
test mat.
Mortality:
The test substance-related death of 2 animals was observed at the dose of 300 mg/kg bw on day 1 and day 2, respectively.
Clinical signs:
In clinical signs, diarrhea, staining around mouth, soiled perineal region were observed in the dose of 300 mg/kg body weight (1st step).
And, soft stool were observed in the dose of 50 mg/kg body weight (2nd, 3rd step).
Soiled perineal region were observed in the dose of 50 mg/kg body weight (3rd step).
Body weight:
In body weight for animal except dead animals, one animal showed body weight decrease in the dose of 300 mg/kg bw (1st step) on 1 day as compared with administration day. One animal showed body weight decrease in the dose of 50 mg/kg bw (2nd step) on 3 days as compared with 1 day. Three animals showed body weight decrease in the dose of 50 mg/kg bw (2nd, 3rd step) on 14 days as compared with 7 days after administration.
Gross pathology:
In the necropsy finding of dead animals, external findings of soiled perineal region were observed and internal findings of retention of test substance in the stomach and enlarged adrenal gland were observed in the dose of 300 mg/kg body weight (1st step). In the necropsy of survived animals, there were no abnormal findings caused by administration of the test substance.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Executive summary:

The acute oral LD50 in rats is determined to >50 mg/kg bw and <300 mg/kg bw based on the results of a study performed according to OECD TG 423. The test dose of 300 mg/kg resulted in death (2 animals), clinical signs such as diarrhea, soft stool, soiled perineal region and staining around mouth, temporary body weight decrease in one animal and necropsy findings such as retention of test substance in the stomach and enlarged adrenal gland.


The test dose of 50 mg/kg resulted in clinical signs such as soft stool and soiled perineal region and temporary body weight decrease. 


In the necropsy of survived animals, there were no abnormal findings caused by administration of the test substance.