Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-03-22 till 2016-04-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The results of the study allow the calculation of the oral LD50 of the test item and permit the test item to be ranked according to most classification systems currently in use.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
EC Number:
221-088-9
EC Name:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
Cas Number:
3001-98-7
Molecular formula:
C7H14O6P2
IUPAC Name:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
Test material form:
solid: particulate/powder
Details on test material:
AFLAMMIT® PCO 962

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000, 5000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg: 1 female
5000 mg/kg: 3 female
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed during the study.
Clinical signs:
All animals were symptom free during the entire study.
Body weight:
Body weight and body weight gain of the animals treated with AFLAMMIT PCO 962
showed no indication of a treatment-related effect.
Gross pathology:
No external or internal macroscopic findings were noted in study animals at necropsy on
Day 14.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item
AFLAMMIT PCO 962 was found to be greater than 5000 mg/kg bw in female
Crl:WI rats.
The study result triggers the following classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 6) 2015: unclassified