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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 11-25 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (OECD 402, EC B.3)
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FLL sample 3
- Chemical name: Oils, fish, oxidized, bisulfited, sodium salts (triglycerides, C12 to C24, even, saturated and unsaturated, bisulfited, sodium salt)
- Physical state: viscous liquid
- Purity: 90%
- Impurities: 10% water content by Karl Fischer
- Lot/batch No.: LS06921
- Expiration date of the lot/batch: 13 October 2010
- Storage condition of test material: room temperature in the dark
- Other: amber color
- All other template details: Not reported

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study:
- Housing: suspended solid-floor polypropylene cages furnished with woodflakes. Animals were housed individually during the 24-hour exposure period and in groups of five by sex for the remainder of the study
- Diet: ad libitum
- 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 per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not reported

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10% of total body surface area
- Type of wrap if used: covered with surgical gauze and self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: the treated skin and surrounding hair was wiped with cotton wool moistened with distilled water
- Time after start of exposure: after 24 hours

TEST MATERIAL
- Amount applied: varied by body weight
- Concentration: 2000 mg/kg
- Constant volume or concentration used: yes

VEHICLE: Not applicable
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: on day of dosing observed at 0.5, 1, 2, and 4 hours then daily observations, weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
Statistics:
Not applicable

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no effects observed at this (highest) concentration
Mortality:
No deaths
Clinical signs:
No signs of systemic toxicity. Very slight to well-defined erythema was noted at the test sites of four females. Haemmorrhage of the dermal capillaries was also noted in two females and small superficial scattered scabs were also noted in one female. The erythema in all animals had subsided by day 7 post-exposure.
Body weight:
Animals showed expected gains in bodyweight over the study period except for one female which showed a loss in bodyweight during the first week but expected gain in bodyweight during the second week.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Not applicable

Any other information on results incl. tables

Not applicable

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 material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

Study summary:

Introduction. A study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to meet the requirements of the following:

·        OECD Guidelines for Testing of Chemicals No 402 “Acute Dermal Toxicity” (adopted 24 February 1987)

·        Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008

 

Method. A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Mortality. There were no deaths.

 

Clinical Observations. There were no signs of systemic toxicity.

 

Dermal Irritation. Very slight to well-defined erythema was noted at the test sites of four females. Small superficial scattered scabs and/or haemorrhage of the dermal capillaries were also noted in two females. No other signs of dermal irritation were noted.

 

Bodyweight. Animals showed expected gains in bodyweight over the study period except for one female which bodyweight loss during the first week but expected gain in bodyweight during the second week.

 

Necropsy. No abnormalities were noted at necropsy.

Conclusion. The acute dermal medial lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.