Oils, fish, sulfated, ammonium salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted to recognised international test guidelines. For read-across justification see Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rape oil, sulfated, sodium salt

EC Number:

281-978-8

EC Name:

Rape oil, sulfated, sodium salt

Cas Number:

84082-30-4

Molecular formula:

not available (substance is a UVCB)

IUPAC Name:

Not applicable

Details on test material:

- Name of test material : CP12
- Physical state: Liquid
- Lot/batch No.: 0012
- Expiration date of the lot/batch: 2015-08-01
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source Charles River Italia S.p.A.
- Age at study initiation: 8 - 10 weeks old
- Weight at study initiation: 208 - 306 g
- Housing: Polysulphone solid bottomed cages measuring 42 .5 x 26.6 x 18 cm
- N° of animal/cage: Group caged (during acclimatisation period); Individually caged (study)
- Diet: 4 RF 18 (Mucedola Srl), available ad libitum
- Water :ad libitum
- Acclimation period:at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°c +/- 2°c
- Humidity (%):55% +/- 15%
- Air changes: 15 to 25 air changes per hour
- Photoperiod: Artificial (fluorescent tubes) , daily light/dark cycle of 12/12 hours

IN-LIFE DATES: From: 2012-09-10 To: 2012-09-25

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 10% of body surface
- Type of wrap if used: synthetic film

REMOVAL OF TEST SUBSTANCE
- Washing : After exposure , the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure:24 hours

TEST MATERIAL
- Amount(s) applied : Aliquots were weighed accordingly to the body weight of each animal measured prior dosing
- Constant volume or concentration used: yes
- Frequency of treatment: once only , on the day of dosing
- Treatment area preparation: on the day before dosing

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - 1,2 and 4 hours after first dosing and daily thereafter for 14 days. Weighing - Days -1, 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None during 14 day post-exposure observation period

Clinical signs:

other: No signs of systemic toxicity observed. Signs of local irritation at treatment site.

Gross pathology:

No abnormal changes considered to be of significance

Other findings:

None

Any other information on results incl. tables

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute toxicity of the substance was investigated following dermal administration of a single dose to the rat at 2000 mg/kg. No mortality occurred following dosing and no signs of systemic toxicity were observed. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.

Executive summary:

The acute toxicity of the substance has been investigated following dermal administration of a single dose to the rat at 2000 mg/kg. utilising OECD/EU test methods. No mortality occurred following dosing and no signs of systemic toxicity were observed. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.