Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
07 October 2015 - 30 November 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amides, from diethylenetriamine and hydrogenated palm oil
EC Number:
810-543-2
Cas Number:
1618093-67-6
Molecular formula:
n/a
IUPAC Name:
Amides, from diethylenetriamine and hydrogenated palm oil
Test material form:
solid: compact
Details on test material:
- Name of test material (as cited in study report): Amidoamine (UVCB)
- Substance type: Amidoamine
- Chemical name: Glycerides, C14-20, reaction products with diethylenetriamine (preliminary naming)/Amides, from diethylenetriamine and hydrogenated palm oil
- CAS 85409-11-6/1618093-67-6
- Physical state: pale yellowish solid at 20 °C
- Batch No.: K8 4309 L481
- Expiry date of batch: 09 March 2017
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Specific details on test material used for the study:
Test item without emulsifier was investigated.

Amidoamine (UVCB)
Pulcra ID: DE07_2014_012_BEL66 (amidoamine without emulsifier)
Physical state: pale yellowish solid at 20 °C
Batch No.: K8 4309 L481
Expiry date of batch: 09 March 2018
Purity: 100 % (UVCB)
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Five male and five female Wistar (RccHan:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals weighed at least 200 g, and were 8 to 12 weeks of age. The weight variation did not exceed ±20% of the mean weight for each sex. The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
Using available information on the toxicity of the test item, a group of five male and five female rats was treated with the test item at a dose level of 2000 mg/kg. The appropriate amount of test item, moistened with arachis oil BP, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area). A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The animals were caged individually for the 24-Hour exposure period. Shortly after dosing the dressings were examined to ensure that they were securely in place.
Duration of exposure:
24-Hour exposure period
Doses:
A group of five male and five female rats was treated with the test item at a dose level of 2000 mg/kg.
No. of animals per sex per dose:
A group of five male and five female rats were treated.
Control animals:
no

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:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals.
Executive summary:

In a Klimisch 1 GLP study from Sander (2015) the acute dermal toxicity of amidoamie test item in male and female Wistar (RccHan:WIST) strain rats with 2000 mg/kg bw was investigated. There were no signs of toxicity and no deaths. All animals gained the expected body weight throughout the whole experimental period and did not elicit gross pathological findings. The LD50 was > 2000 mg/kg bw. In conclusion, there is no hazard for acute dermal toxicity.

Categories Display