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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17-04-2013 to 01-05-2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to the guideline under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
EC Number:
806-509-1
Cas Number:
1393571-42-0
Molecular formula:
NA
IUPAC Name:
Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
Constituent 2
Reference substance name:
Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
IUPAC Name:
Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
Test material form:
other: extremely viscous liquid
Details on test material:
- Name of test material (as cited in study report): Fatty acids, tall oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and methylhydrogen maleate
- Substance type: UVCB
- Physical state: extremely viscous liquid
- Storage condition of test material: room temperature in dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 152-160 g
- Housing: 1/cage in solid-floor polypropylene cages furnished with woodflakes during application, 5/sex/cage thereafter
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30-70%
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
application site (ca.10% of body surface) was moistered with arachis oil BP before application
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily; body weight on day 0 (before treatment), day 7 and 14, clinical observations(including irritation) daily (0.5, 1, 2 and 4 hours after dosing)
- Necropsy of survivors performed: yes
Statistics:
NA, limit test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: very slight erythema, scabs and slight desquamation (glossy skin)
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 is > 2000 mg/kg bw
Executive summary:

Groups of 5 rats/sex received a dermal application of 2000 mg/kg test substance during 24 hours under semi-occlusion. No effects other than slight irritation were found during the 14 day observation period. The dermal LD50 of the test substance is > 2000 mg/kg bw.