Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study, available as unpublished report, no restrictions, fully adequate for assessment. Standard Operating Procedure are applied from the Lead Registrant to analyze the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Epoxide acetonide acetate
IUPAC Name:
Epoxide acetonide acetate
Details on test material:
- Name of test material (as cited in study report): Epoxide acetonide acetate
- Substance type: Organic
- Physical state: White or almost white, crystalline powder
- Analytical purity: 94.39%
- Impurities (identity and concentrations): unknown impurities 5.61%; Largest unspecified imputity: 1.13%
- Purity test date: 29/05/2012
- Lot/batch No.: 31007TO 3100T0.2.12
- Expiration date of the lot/batch: 5 year
- Stability under test conditions: stable

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
crystalline
Colour:
Light brown.
Substance type:
organic

Applicant's summary and conclusion

Conclusions:
Characteristics of the product are obtained directly from the Standard Operating Procedure applied from the Lead Registrant to analyze the substance.