Registration Dossier

Diss Factsheets

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: according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Ca-/Mg-salt of Fumarated Tall Oil Rosin
IUPAC Name:
Ca-/Mg-salt of Fumarated Tall Oil Rosin
Details on test material:
Batch No.: Laboransatz 1916
content of the test item 100 % :
Appearance: beige powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 289-300 g (males; 228-242 g (females)
- Housing: individually
- Diet ad libitum:
- Water ad libitum:
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
the pure powder was transferred to a wet gauze-layer
Details on dermal exposure:
For each dose and amimal the required amount of solid test substance was calculated on the base of the body weight at time of dosing. The amount was weighed and transferred to a wet gauze layer and was placed on the back of rats and was covered semi-occlusively for approximately 24 hours.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
other: the opposite site of the back of each animal
Details on study design:
One day before the start of the treatment the back and the flank of the rats were shorn. For each dose and amimal the required amount of solid test substance was calculated on the base of the body weight at time of dosing. The amount was weighed and transferred to a wet gauze layer and was placed on the back of rats and was covered semi-occlusively for approximately 24 hours. After removal of the dressing the treated areas were rinsed with water and soap and gently patting the area dry. Post exposure observation period: 14 days
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died and no animal displayed clinical pathological signs
Mortality:
No animal died
Clinical signs:
No clinical pathological signs were observed
Body weight:
There were no toxicologically significant effects on body weight or body weight development in males and females
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

Acute dermal toxicity was tested according to OECD TG 402 and GLP.

2000 mg/ kg bw test substance was applied to the back of male snd female Wistar rats for 24 hours covered by a semi occlusive dressing. After removal of the dressing and the test substance the animals were observed for further 14 days. No mortality occurred and no clinical signs or effects on body weight development were observed. Gross pathological examination revealed no findings. Thus, the LD50 (dermal, rat) is > 2000 mg/kg bw under the condition of this test (Bayer Pharma AG 2011).