Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer reviewed data from the EU Risk Assessment Report for TCPP

Data source

Reference
Reference Type:
publication
Title:
EU RAR (2008) European Union Risk Assessment Report TRIS(2-CHLORO-1-METHYLETHYL) PHOSPHATE (TCPP) CAS No: 13674-84-5, EINECS No: 237-158-7,
Author:
EC
Year:
2008
Bibliographic source:
EU RAR (2008) European Union Risk Assessment Report TRIS(2-CHLORO-1-METHYLETHYL) PHOSPHATE (TCPP) CAS No: 13674-84-5, EINECS No: 237-158-7, European Communities, May 2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no data
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Route of administration:
oral: feed
No. of animals per sex per dose:
20

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Study observed:

There were no treatment-related mortalities. No clinical observations were considered to be related to treatment.

 

LOAEL = 52 mg/kg/day (males) [increase in absolute and relative liver weights, accompanied by mild thyroid

follicular cell hyperplasia]

 

NOAEL = 171 mg/kg/day (females) [increased liver weights

observed in females dosed at 7,500 ppm and above.]

 

Applicant's summary and conclusion

Executive summary:

LOAEL = 52 mg/kg/day (males) [increase in absolute and relative liver weights, accompanied by mild thyroid

follicular cell hyperplasia]