Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (incomplete documentation, occlusive treatment, 24 h exposure)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(occlusive treatment, 24 h exposure)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Purity: 100%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga, Ottobrunn, Germany
- Mean weight at study initiation: males 136 g, females 119 g

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% solution in water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal, p.c., 50 cm²
- % coverage: considered to be > 10 % (mean bw of 136 g, calculated with the formula " surface area = 9.1 x bw (exp) 0.67"
- Type of wrap if used: no data
- Site of exposure: dorsal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water containing mild detergent
- Time after start of exposure: no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg bw (5mL/kg bw)
- Concentration (if solution): 50 % suspension solution (in water 0.5% CMC)
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before application
- Frequency of observations: daily (on working days: day 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14)
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no clinical signs were observed.
Mortality:
No mortality ocurred.
Clinical signs:
No clinical signs were observed.
Body weight:
no data
Gross pathology:
No abnormalities were observed.
Other findings:
- Other observations: after 24 h and 8 days: local yellow substance residues

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU