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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July-September 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-butyliminodiethanol
EC Number:
203-055-0
EC Name:
2,2'-butyliminodiethanol
Cas Number:
102-79-4
Molecular formula:
C8H19NO2
IUPAC Name:
2,2'-(butylimino)diethanol
Details on test material:
- Name of test material (as cited in study report): n-Butyldiethanolamine CAS No. 102-79-4
- Substance type: alkylalkanolamine
- Physical state: clear colorless liquid
- Analytical purity: 98.95%
- Purity test date: 2014-04-07
- Lot/batch No.: U140127DVN
- Expiration date of the lot/batch: 30 January 2015
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark
- Other:

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Wistar (RccHan:WIST) strain
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: at least 200 g (the weight variation did not exceed ±20% of the mean weight for each sex).
- Fasting period before study: no
- Housing: individually during the 24-Hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet (e.g. ad libitum): ad libitum (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Water (e.g. ad libitum): ad libitum (mains drinking water)
- Acclimation period: at least five days

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

IN-LIFE DATES: From: 07 August 2014 To: 21 August 2014

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: backs and flanks
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin and surrounding hair were wiped with cotton wool moistened with distilled water to remove any residual test item.
- Time after start of exposure: 24 hours

TEST MATERIAL
For the purpose of the study the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
- Amount(s) applied (volume or weight with unit): 2.08 (based on specific gravity of 0.966)
- Constant volume used: yes

Duration of exposure:
24 hours
Doses:
The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual body weights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No treatment related effects
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:
- Other observations: dermal reactions.
Very slight erythema was noted at the test site of one male. Very slight erythema, small superficial scattered scabs and glossy skin were noted at the test sites of four females.
There were no signs of dermal irritation noted at the test sites of four males and one female.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths or signs of systemic toxicity. Very slight erythema was noted at the test sites of one male and four females. Small superficial scattered scabs and glossy skin were also noted at the test sites of four females. There were no signs of dermal irritation noted at the test sites of four males and one female. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.

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 Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

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