Registration Dossier

Administrative data

Endpoint:
flash point of flammable liquids
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 27, 2012 - September 18, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (OECD102) with acceptable restrictions
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
GLP compliance:
no
Type of method:
thermal analysis
Decomposition:
yes
Decomp. temp.:
>= 180 °C

In all three measurements a broad exothermal effect could be observed in a temperature range of 190 – 360 °C with a decomposition energy of -190 J/g (mean value). In all three measurements a mass loss of approximately 68 % could be observed.

Table: Results on melting and boiling point

No.

Sample weight / mg

Start of effect / °C

Energy /
J/g

Remark

PN4233

13.94

200

-190 (exothermal)

PN4242

10.58

210

-170 (exothermal)

PN4262

12.04

190

-210(exothermal)

Conclusions:
According to OECD Test Guidelines 102 and 103, and EC No. 440/2008 Part A. Method A.1. and A.2., the test item 7-Aminocephalosporanic acid has no melting and no boiling point at atmospheric pressure (1013 hPa). It decomposes firstly at a temperature of 180 °C.
Executive summary:

According to OECD Test Guidelines 102 and 103, and EC No. 440/2008 Part A. Method A.1. and A.2., the test item 7-Aminocephalosporanic acid has no melting and no boiling point at atmospheric pressure (1013 hPa). It decomposes firstly at a temperature of 180 °C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion