Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
read-across: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
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:
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:
No dermal reactions nor systemic clinical signs were observed
Body weight:
No changes in body weight 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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
No dermal reactions nor systemic clinical signs were observed
Body weight:
No changes in body weight 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.