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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
Study period:
2012-03-01 to 2012-03-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of test material: Trimethylolpropanepoly(oxypropylene)triamine
EC no.: 500-105-6
CAS no.: 39423-51-3
Physical state: clear colourless liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1L708
- Composition of test material, percentage of components: 96% primair amine, 0.08 wt%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, 15 to 30°C

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan
- Age at study initiation: 9 to 11 weeks at start of dosing
- Weight at study initiation: 195 to 221 grams
- Fasting period before study: overnight
- Housing: Animals were group housed by sex upon receipt and individually housed during the study. No other species were kept in the same room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum of 5 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 24°C
- Humidity (%): 20 to 63%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 1 March 2012 To: 30 March 2012

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
at 175mg/kg dose only (low dose)
Details on oral exposure:
Dose preparation:
The proper amount of the test article was measured according to volume since it was a liquid, and was allocated/dosed neat as received from the Sponsor at 2000 and 550 mg/kg with a pH = 7. The stock bottle was inverted several times prior to dispensing. At 175 mg/kg the test article was dissolved in distilled water (175 mg brought to a volume of 5 mL). The resulting clear liquid had a pH equal to 12.
Doses:
175, 550 or 2000 mg/kg body-weight
No. of animals per sex per dose:
A total of 6 females: 175 (1), 550 (3) and 2000 mg/kg (2)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality checks were made at least once daily. Clinical observations were recorded prior to dosing, as well as at 30 minutes, 4 hours post-dose, and daily thereafter through day 15. Body weights were recorded on the day of dosing (day 1), and on days 8 and 15, or upon death. All surviving rats were euthanized by CO2 asphyxiation and necropsied on Day 15.
- Necropsy of survivors performed: yes
Statistics:
The LD50 was calculated test using the AOT425StatPgm developed by Westat May, 2001.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
550 mg/kg bw
Based on:
test mat.
95% CL:
123.9 - 3 930
Mortality:
For the dose of 175 mg/kg, no mortality was observed. One of three animals receiving the test article at 550 mg/kg was found dead and both animals at 2000 mg/kg were found dead. All three deaths occurred by the 30 minute observation time point on day 1.
Clinical signs:
No clinical signs were observed and all surviving animals appeared normal throughout the study.
Body weight:
No biologically significant effect was seen on body weights of the surviving animals on days 8 and 15.
Gross pathology:
Terminal necropsy revealed no visible lesions in the surviving animals at 175 and 550 mg/kg. Necropsy of the animals found dead revealed test article visible in the stomach but no other visible lesions.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the results of this study, the oral LD50 for the test substance in rats was estimated to be 550 mg/kg (95% PL Confidence Interval of 123.9 to 3930 mg/kg). Therefore, the test substance is considered to be classified as category 4 according to the CLP regulation.