Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A well performed study according to OECD Guideline 402 in 1993, but eg. no description of pathological examination after autopsy. Only a remark that autopsy was performed.

Data source

Reference
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guidline No 402, Acute Dermal Toxicity, Feb 1987, and Annex to 92/69/EEC of 31/7 92 part B.3.
Principles of method if other than guideline:
Fixed dose, only one dose level.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: SPF Wistar rats of the strain MOL: WIST
Strain:
other: SPF Wistar rats of the strain MOL: WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Möllegard Breeding Centre Ltd, Eljby , DK-4623 Lille Skensved Denmark.
- Age at study initiation:7-10 weeks
- Weight at study initiation: 210-237 g
- Fasting period before study: No fasting period.
- Housing: Cages Type II 42x26x15 cm, 2 or 3 in each cage. Bedding sawdust, Hahnflock H 3/4.
- Diet (e.g. ad libitum): ad libitum rodent diet Altroim 1314
- Water (e.g. ad libitum): Water acidified with HCl to pH 2.5
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes (per hr):10 times/day
- Photoperiod (hrs dark / hrs light):12 hrs light/12 hrs dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Sesam oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 6x8 cm
- % coverage: 100 %
- Type of wrap if used: 4 layer gauze pack fixed with Scanpor tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With soap and lukewarm water
- Time after start of exposure:24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2000 mg/bw
- Concentration (if solution): Not specified
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit):Sesam oil.
- Concentration (if solution): Not specified

Duration of exposure:
24 h
Doses:
2000 mg/bw
No. of animals per sex per dose:
2000 mg/bw for 5 male and 5 female rats.
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1,3 and 6 hrs after application and then daily during 14 days.
- Necropsy of survivors performed: Yes, but no details about organs and findings, except a remark of no signs in the pathological examination. No histopathological details.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: None.
Day one, the animals showed signs of sedation, but it is probably a consequence of the immobilisation of the animals in the test.
Body weight:
Normal body weight gain during the test.
Gross pathology:
Effects on organs:
none
Other findings:
Signs of toxicity (local):
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The conclusion of the registrant is that Gelpase urea isn't toxic or harmful by the route of dermal exposure.