Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 Nov - 05 Dec 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom, UK
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydrogenated Trimer Fatty Acid
- Physical state: amber coloured viscous liquid
- Substance type: UVCB
- Analytical purity: 100%
- Lot/batch No.: 12-92-29
- Expiration date of the lot/batch: 08 Mar 2014
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
other: RccHan™:WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 235-273 g (males); 200-216 g (females)
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24 h exposure period and in groups of up to four, by sex, for the remainder of the study.
- Diet: 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: unchanged (no vehicle), moistened with arachis oil BP
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks (clipped free of hair)
- % coverage: approx. 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: The treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: For the purpose of the study the test item was weighed out according to each animal’s individual bodyweight and moistened with arachis oil BP prior to application.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Procedure: Initially, two animals (one male and one female) were given a single, 24-hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Based on the results of theinitial test, a further group of eight animals (four males and four females) was similarly treated.
- 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 bodyweights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy (external examination and opening of the abdominal and thoracic cavities; the appearance of any macroscopic abnormalities was recorded; no tissues were retained), dermal reactions

DERMAL REACTIONS
After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.



Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
Animals showed expected gains in bodyweight over the study period except for one female which showed bodyweight loss during the first week (ca. -7%) but expected gain in bodyweight during the second week.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Dermal reactions: Very slight erythema was noted at the test sites of eight animals (Table 1). Small superficial scattered scabs were also noted at the test sites of three females. There were no signs of dermal irritation noted in two males.

Any other information on results incl. tables

Table 1. Individual dermal reactions

Animal number

Observation

Effects noted after initiation of exposure (Days)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Males

1

Erythema

0

1

1

1

1

0

0

0

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

Erythema

0

1

0

0

0

0

0

0

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4

Erythema

0

1

0

0

0

0

0

0

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Females

1

Erythema

0

1

1

1

1

1

1

1

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Other

0

0

Ss

Ss

Ss

Ss

Ss

Ss

Ss

Ss

0

0

0

0

2

Erythema

0

1

1

0

0

0

0

x

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

x

0

0

0

0

0

0

 

Other

0

Ss

Ss

0

0

0

0

x

0

0

0

0

0

0

3

Erythema

0

1

1

0

0

0

0

x

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

x

0

0

0

0

0

0

 

Other

0

0

0

0

0

0

0

x

0

0

0

0

0

0

4

Erythema

0

1

1

0

0

0

0

x

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

x

0

0

0

0

0

0

 

Other

0

0

0

0

0

0

0

x

0

0

0

0

0

0

5

Erythema

0

1

1

0

0

0

0

x

0

0

0

0

0

0

 

Edema

0

0

0

0

0

0

0

x

0

0

0

0

0

0

 

Other

0

Ss

Ss

0

0

0

0

x

0

0

0

0

0

0

 

0 = No reactions

1 = Very slight erythema

Ss = Small superficial scattered scabs

x = Due to technician error observation not performed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified