Rosin, fumarated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant, guideline study, available as an unpublished report, reliable without restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rosin fumarated

IUPAC Name:

Rosin fumarated

Constituent 2

Reference substance name:

Rosin, fumarated

EC Number:

266-040-8

EC Name:

Rosin, fumarated

Cas Number:

65997-04-8

Molecular formula:

Not applicable as the substance is a UVCB

IUPAC Name:

Rosin, fumarated

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): Rosin fumarated
- CAS no: 65997-04-8
- Substance type: UVCB
- Physical state: Form
- Colour: orange
- Analytical purity: 100%
- Lot/batch No.: 9089375
- Production date: 07 June 2012
- Quantity: 67.29 g (container+content)
- Expiration date of the lot/batch: 07 June 2013
- Storage condition of test material: Room temperature, darkness

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle- France)
- Age at study initiation: Male: 7 weeks old. Females: 8 weeks old
- Weight at study initiation: Male: 229-250g. Females: 200-215
- Housing: Animals were individually housed for the 24 hrs treatments; animals were grouped in 5 for the rest of the study
- Diet (e.g. ad libitum): freely supplied (M20-SDS)
- Water (e.g. ad libitum): tap water from public distribution system
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs darkness ( 07.00 am/19.00pm)

Administration / exposure

Type of coverage:

semiocclusive

Details on dermal exposure:

TEST SITE
- Area of exposure: 10% of the dorsal areal of the trunk
- % coverage: 100%
- Type of wrap if used: semi occlusive dressing (porous gauze patches hydrophilic Codex of 8 layer Gazin from Lohmann&Rauscher held in contact with the skin by means of 50 mm wide hypoallergenic micropore adhesive tape from 3M)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the gauze dressing were removed and the treated areas were rinsed with dimethyl sulfoxide.
- Time after start of exposure: 24hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight (2 or 4 g of the test item was weighted and dimethyl sulfoxide was added to a 10 or 20 mL volumetric flask.

Duration of exposure:

24 hrs

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: Daily examinations were carried out to identify any behavioural or toxic effects on the physiological functions during 14 days following the administration of the test material. The animals were weighed on day D0, D2, D7 and D14.

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 mortality, no systemic clinical signs

Mortality:

No mortality

Clinical signs:

other: other: No systemic clinical signs related to the administration of the test item

Other findings:

The microscopic examination of the animals was conducted at the end of the study. The result did not reveal treatment-related changes.
Erythema and yellow coloration of the treated area were noted from 24 hrs post-dose in all animals and were totally reversible on D8.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of the test item Rosin fumarated, CAS No. 65997-04-8 is higher than 2000 mg/kg body weight.

Executive summary:

The acute dermal toxicity of Rosin fumarated was evaluated using 5 male and 5 female Sprague Dawley rats. The fur was removed from the dorsal area of the trunk of the animals by clipping and a dose of 2000 mg/kg body weight was applied onto the 10% of the clear skin for 24 hrs. The treated area was covered by a semi-occlusive dressing consisting of a gauze patches hydrophilic, which was held in contact with the skin by means od 50 mm wide hypoallergenic micropore adhesive tape. After 24 hrs exposure, the gauze was removed and the treated area was rinsed with dimethyl sulfoxide.

The animals were observed for 24 hrs. Signs of toxicity and behavioural effect were recorded daily, while weight gain was recorded at D0, D2, D7 and D14. No mortality occurred during the study. The results showed no signs of toxicity related to the administration of the test material. Erythema and yellow coloration of the treated area were noted from 24 hrs post-dose in all animals and were totally reversible on D8. No change in body weight was recorded and macroscopic examination did not show any treatment related changes.

In conclusion, the LD50 of Rosin fumarated is higher than 2000 mg/kg body weight.