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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 September 2012 to 26 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Fully GLP compliant and in accordance with current test guidelines

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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Test material form:
other: Viscous semi-solid
Details on test material:
Name: MonoFA_TETA_PAA_BADGE_BGE_Adduct
CAS number: 105839-18-7
Batch number: WA521
Purity: 100%
Expiry date: 28 Feb 2014
Receipt at Covance: 03 Sep 2012
Storage: stored in a sealed container, at room temperature, in the dark.

Test animals

Species:
rat
Strain:
other: HsdHan:WIST
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 250 to 279 g (males) and 175 to 203 g (females)
- Fasting period before study: Not applicable
- Housing: up to five rats of the same sex were accommodated in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989). From the day prior to dosing (Day –1), each rat was individually housed in a similar cage. After completion of the Day 3 observations animals allocated to the main study were returned to group housing.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, ad libitum
- Water (e.g. ad libitum): Mains water, ad libitum
- Acclimation period: 7 to 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): The animal rooms were designed to permit 15 to 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by fluorescent strip-lights for twelve hours daily.

IN-LIFE DATES: From: 01 October 2012 To: 23 October 2012

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsum
- % coverage: 10%
- Type of wrap if used: Dense gauze patch retained by elasticated open-eave adhesive compression bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool
- Time after start of exposure: 24 Hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable
Duration of exposure:
15 Days
Doses:
1 Dose
No. of animals per sex per dose:
Five male and five female rats were subjected to single dermal application of the test article at 2000 mg/kg. This group consisted of the two animals used in the preliminary test plus a further four male and four female rats to give the required group size of five males and five females.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Rats were weighed on Day -1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal signs
Statistics:
Not Applicable

Results and discussion

Preliminary study:
A pair of animals (one male and one female) received a single dermal dose of test article at a dose level of 2000 mg/kg.,(no compound related mortality. was observed).
Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no clinical signs of reaction to treatment.
Body weight:
All rats gained weight during the first and second weeks of the study except for one female which showed a slight loss in body weight during the first week.
Gross pathology:
Abnormalities noted at necropsy were confined to a sore appearance of the skin at the treatment site and an isolated incident of pale mucosal surface of the stomach.
Other findings:
Very slight to well-defined erythema was noted in all animals on Day 2. Very slight erythema was noted in two animals up to Day 6 and persisted in one animal until the end of the observation period.
Other adverse dermal reactions noted were brown discolouration of the skin, scabbing and new skin growth.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute median lethal dermal dose of MonoFA_TETA_PAA_BADGE_BGE_Adduct to rats was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute dermal toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Executive summary:

This study was conducted to determine the acute dermal toxicity of the test article, MonoFA_TETA_PAA_BADGE_BGE_Adduct, following a single (24 hour) semi-occluded topical application to the rat.

The test article was applied undiluted to the clipped dorsum of a group of five male and five female rats on Day 1. Each rat received a single topical application at a dose level of 2000 mg/kg. The treated areas of dorsum were covered by a semi-occlusive dressing for 24 hours. All animals were killed on Day 15 and subsequently underwent a full necropsy.

There were no deaths and no clinical signs of reaction to treatment.

Adverse dermal reactions noted were very slight to well-defined erythema, brown discolouration of the skin, scabbing and new skin growth.

All rats gained weight during the first and second weeks of the study except for one female which showed a slight loss in body weight during the first week.

Abnormalities noted at necropsy were confined to a sore appearance of the skin at the treatment site and an isolated incident of pale mucosal surface of the stomach.

The acute median lethal dermal dose of MonoFA_TETA_PAA_BADGE_BGE_Adduct to rats was found to exceed 2000 mg/kg.

The test material was considered to have no significant acute toxic risk in respect of its acute dermal toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).