Resin acids and Rosin acids, polymd., esters with glycerol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality, clinical signs, dermal reactions or gross pathology observed.

Mortality:

No mortality occurred

Clinical signs:

other: other: No dermal reactions nor systemic clinical signs were observed

Gross pathology:

The gross pathogy examination did not reveal treatment- related changes.

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of the test material Resin acids and rosin acids, hydrogenated methyl ester is >2000 mg/kg/bw.

Executive summary:

This data is being read across from the source study that tested Resin acids and Rosin acids, hydrogenated, methyl esters based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

In an acute dermal toxity study, a single treatment of 2000 mg/kg/bw of Resin acid and rosin acid, hydrogenated methyl ester was applied to clipped skin on the dorsal trunk of 10 Sprague Dawley rats (5 male and 5 female) for 24 hrs under semi-occlusion. Under the conditions of the study, no mortality occurred and no dermal reactions or systemic clinical signs observed. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. In conclusion, the acute dermal LD50 of Resin acids and rosin acids, hydrogenated methyl ester was >2000 mg/kg/bw.

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:

Resin acids and Rosin acids, hydrogenated methyl ester

IUPAC Name:

Resin acids and Rosin acids, hydrogenated methyl ester

Constituent 2

Reference substance name:

Resin acids and Rosin acids, hydrogenated, Me esters

EC Number:

232-476-2

EC Name:

Resin acids and Rosin acids, hydrogenated, Me esters

Cas Number:

8050-15-5

Molecular formula:

Not applicable for UVCB constituents

IUPAC Name:

Resin acids and Rosin acids, hydrogenated, Me esters

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Foralyn (TM) 5020-F Ester of Hydrogenated Rosin
- Substance type: UVCB
- Physical state: liquid
- Colour: yellow
- Quantity: 1000.89 g (container+ contents)
- Analytical purity: 100%
- Lot/batch No.: KM001
- Expiration date of the lot/batch: 2013/01/06
- 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: Janvier (53940 Le Genest St Isle- France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: 220-224 g
- Fasting period before study:
- Housing: individual cages with solid-bottomed clear polycarbonate cages with a stailess steel mesh lid. Each cage contained dust free weed shavings which were changed at least 2 times a week.
- Diet (e.g. ad libitum): foodstuff (M20-SDS) freely available
- 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 (%): 70%
- Air changes (per hr): 10-15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 100%
- Type of wrap if used: porous gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated areas were rinsed with distilled water after 24 hrs exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg/bw (according to the calculated density)
- Dose: 2000 mg/kg/bw

Duration of exposure:

24 hrs

Doses:

2000 mg/kg/bw

No. of animals per sex per dose:

5 male rats and 5 female rats

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily: systematic examination were carried out daily to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. Periodical: Animals were weighed on D0, D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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, clinical signs, dermal reactions or gross pathology observed.

Mortality:

No mortality occurred

Clinical signs:

other: other: No dermal reactions nor systemic clinical signs were observed

Gross pathology:

The gross pathogy examination did not reveal treatment- related changes.

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 material Resin acids and rosin acids, hydrogenated methyl ester is >2000 mg/kg/bw.

Executive summary:

In an acute dermal toxity study, a single treatment of 2000 mg/kg/bw of Resin acid and rosin acid, hydrogenated methyl ester was applied to clipped skin on the dorsal trunk of 10 Sprague Dawley rats (5 male and 5 female) for 24 hrs under semi-occlusion. Under the conditions of the study, no mortality occurred and no dermal reactions or systemic clinical signs observed. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. In conclusion, the acute dermal LD50 of Resin acids and rosin acids, hydrogenated methyl ester was >2000 mg/kg/bw.