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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 October 2003 to 11 February 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Fully Guideline- and GLP-compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Resin 835 A (Lot:0161852)
- Molecular formula (if other than submission substance): main component C20H28O2
- Molecular weight (if other than submission substance): main component 300 g/mol
- Physical state: solid melt
- Composition of test material, percentage (w/w) of components: 56 % dehydroabietic acid, 20 % dihydroabietic acid, 9.8 % neutral components, 9 % non ident. rosin acids, 4 % Pimaric acids
- Purity test date: 11 March 2003 and 4 September 2003
- Lot/batch No.: 0161852
- Expiration date of the lot/batch: 17 June 2004
- Storage condition of test material: at approx. 20 °C in a fume cupboard

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, 33178 Borchen, Germany
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation (means): 256 g (males) and 222 g (females)
- Fasting period before study: no
- Housing: single caging, Macrolon cages type III on soft wood granulate
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad lib.
- Water (e.g. ad libitum): tap water, ad lib.
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 5 November 2003 To: 19 November 2003

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: sesame oil
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin
- coverage: 30 cm2
- Type of wrap if used: two-ply gauze, aluminium foil, elastic plaster bandage (Fixomull and Elastoplast)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied: 0.5 g
- Constant volume or concentration used: yes
- For solids, paste formed: moistened with 0.3 mL sesame oil


VEHICLE
- Amount(s) applied: 0.3 mL for moistening
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily (on weekends and holidays once daily); Weighing weekly
- Necropsy of survivors performed: yes
Statistics:
no statistics performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no symptoms in any animal, no signs of skin irritation
Body weight:
slight body weight loss in 2/10 animals in the first study week, body weight development not impaired in 8/10 animals
Gross pathology:
no macroscopically visible changes
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute dermal toxicity testing of Resin 835 A (Lot:0161852) in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both maleand female animals.
Executive summary:

Acute dermal toxicity testing of Resin 835 A (Lot:0161852) in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals.

After administration of 2000 mg/kg body weight neither deaths nor symptoms occurred.

The skin of the animals showed no signs of irritation.

Development of body weight was not impaired in eight animals, the other two animals showed a slight loss of body weight in the first study week.

All animals were killed at the end of the observation period. They showed no macroscopically visible changes.