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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-05 to 2012-06
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

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
- Purity test date: 21/11/2011

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp (19-27°C)
- Stability under test conditions: no data

OTHER SPECIFICS:
- Analytical purity: 96% primary amine

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 190-234 g
- Fasting period before study: no data
- Housing: grouped by sex upon receipt; individually housed upon assignment to study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min 5d prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 24-89%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark

IN-LIFE DATES: From: 31 May 2012 To: 14 June 2012

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: > 10%
- Type of wrap if used: elastic bandage, secured with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped appropriately with gauze and water
- Time after start of exposure: 24h (+/- 0.5h)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1000 mg/kg
- Concentration (if solution): 0.978 g/ml
- Constant volume or concentration used: yes

VEHICLE: no vehicle
Duration of exposure:
24h (+/- 0.5h)
Doses:
1000 mg/kg
No. of animals per sex per dose:
5 per sex
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality: once daily
clinical observations: immediately after unwrap + daily thereafter through day 15
weighing on day1, day8, day15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external body surface, all orifices, thoracic, abdominal and pelvic cavaties and their content.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No mortality observed
Clinical signs:
7/10: some signs of irritation at the application site starting on day 4, with all irritation resolved by day 14.
No necrosis observed
Body weight:
No effect on body weight observed (weight gain on day 8 and 15)
Gross pathology:
No visible lesions observed in the animals at terminal necropsy

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the results of the acute dermal toxicity study in rats with the test substance, the estimated LD50 was considered to be greater than 1000 mg/kg bw. Therefore, the substance is considered to be classified as category 4 according to CLP regulation.