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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
EC Number:
423-340-5
EC Name:
Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
Cas Number:
162881-26-7
Molecular formula:
C26H27O3P
IUPAC Name:
[phenyl(2,4,6-trimethylbenzoyl)phosphoryl](2,4,6-trimethylphenyl)methanone
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

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

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 1% metthylcellulose
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days plus 2 week recovery period for control (5 males/5 females) and top dose animals (5 males/5 females).
Frequency of treatment:
The test substance in a 1% metthylcellulose vehicle (1o ml) was administered daily by gavage.
Doses / concentrations
Remarks:
Doses / Concentrations:
15, 150 and 1000 mg/kg bw/day
Basis:
other: nominal in test vehicle
No. of animals per sex per dose:
10 males and 10 females in the control group
5 males and 5 females at 15 /mg/kg bw/day
5 males and 5 females at 150 /mg/kg bw/day
10 males and 10 females at 1000 /mg/kg bw/day
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
One female was foun dead in week one, but this was considered to be accidental.
Sacrifice and pathology:
No treatment-related changes were observed.
Other examinations:
Neutrophils were increased in top dose males. Decreases in alkaline phosphatase and AST were seen in top dose males and mid and top dose females, respectively. All values were normal after 2 weeks recovery.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related changes were obersved.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test substance was of low toxicity when administered daily over a 28-day period.
Executive summary:

No signs of systemic toxicity have been observed in the repeated dose toxicity study. Based on the information obtained this study, the substance does not need to be classified for repeated dose toxicity, according to the Regulation EC 1272/2008 and the Directive 67/584/EEC.