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
Study period:
1988-07-12 to 1988-07-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: - Guideline study with acceptable restrictions (e.g. size of application area not reported)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
as at 1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
as at 1984
Deviations:
no
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
other: Russian White (albino)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Asta Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 18 - 24 weeks (males) 22 - 24 weeks (females)
- Weight at study initiation: 2.19 - 2.31 kg (males), 2.49 - 2.65 kg (females)
- Fasting period before study: food withheld at day of application start
- Housing: 1 per cage (stainless steel cages model ASTA, ASTA Pharma AG, D-4800 Bielefeld 14)
- Diet: not reported
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 45 - 65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
paraffin oil
Details on dermal exposure:
TEST SITE
- Area of exposure: between shoulder and os sacrum
- % coverage: not reported
- Type of wrap if used: not reported

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: yes, 1g of test substance moistured in 0.567 ml paraffin oil (vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 4-8 h post application, daily thereafter; Frequency of weighing: day 1, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology of skin of the application site, other: gross necroscopy
Statistics:
- not applicable as no deaths occurred during the test procedure

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
- no deaths occurred during the test period
Clinical signs:
- No systemic toxicity. At the application site: red/brown staining, swelling and hardening
- Staining and swelling reversed between day 8 and day 13
Body weight:
- slight decrease, see table 1
Gross pathology:
- no lesions in internal organs were found
- Pathology findings in the skin at the application site included: acanthosis, hyperkeratosis, subepidermal mixed inflammatory cell infiltration, erosion, superficial exudate, subepidermal haemorrhages, ulceration, epidermal proliferation, secondary built hairfollicle cysts, epidermal necrosis and slight pustule forming

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of this acute dermal toxicity study a combined LD50 for both sexes of > 2000 mg/Kg was deduced in rabbits.