Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

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
Details on test material:
- Name of test material (as cited in study report): AA-370-116 Resin acid and rosin acids, fumarated, esters with pentaerythritol
- Substance type: UVCB
- Physical state: solid
- Colour: yellow
- Quantity: 72.73 g (container+ contents)
- Analytical purity: 100%
- Lot/batch No.: 23248
- Expiration date of the lot/batch: Indefinate
- Storage condition of test material: -20° C, darkness

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
Key result
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 materialResin acid and Rosin acid, fumareted, ester with pentaerythitritol 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 acids, fumarated, ester with pentaerythritol 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 were observed. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. In conclusion, the acute dermal LD50 of Resin acid and rosin acids, fumarated, ester with pentaerythritol was >2000 mg/kg/bw.