Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 July 1992 - 16 July 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although a good quality report and conducted to GLP and documented test parameters are based on specific national guidelines, the purity of test substance is not reported and actual guidelines refs not quoted in test report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
No official test guidelines were cited, although on review of the test report, the methodology used was broadly consistent with OECD test guideline 402.
GLP compliance:
yes
Remarks:
The test report includes a statement of GLP compliance signed by the Study Director, and a statement of Quality Assurance, however no certificate of GLP compliance issued by an independant body (such as an official GLP monitoring authority) was included.
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MMB-Ac
- Physical state: Colourless liquid
- Lot/batch No.: 32840
- Storage condition of test material: Stored in the dark, under ambient conditions.
- Other: Specific gravity = 0.96

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities and no abnormal clinical signs were observed in any of the 5 males and 5 females dosed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information According to the criteria described in EU Directive 67/548/EEC, the substance is not classified as dangerous based on acute dermal toxicity. Criteria used for interpretation of results: EU
Conclusions:
The Median Dermal Lethal Dose (LD50) of MMB-Ac in rats is greater than 2000 mg/kg.