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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Acute toxicity (oral): LD50 (male/female) >5000 mg/kg bw

Acute toxicity (inhalation): Waiver

Acute toxicity (dermal): LD50 (male/female) >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Compliance, not OECD guideline
Qualifier:
according to guideline
Guideline:
other: EPA-guideline 798.1175 (based on Directive 92/69/EEC,B.1)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
other: Rat, Sprague Dawley
Vehicle:
other: 0.5 % aqueous methylcellulose
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 3150 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths:0
Female: 3150 mg/kg bw; Number of animals: 5; Number of deaths:0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: MORTALITY: All animals survived through the 14-day observation period. BODY WEIGHT: The body weight was within the normal range. ANIMAL OBSERVATION: Light colored feces were observed in all animals on day 1. Wi
Gross pathology:
Effects on organs:
No findings considered treatment related were noted at necropsy.
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Information from migrated NONS file, as per inquiry number 06-2120077351-60-0000, permission to refer granted by ECHA.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Compliance, not OECD guideline
Qualifier:
according to guideline
Guideline:
other: Directive 92/69 EEC, B.3
GLP compliance:
yes
Limit test:
yes
Species:
other: Rat, WISTAR
Type of coverage:
semiocclusive
Vehicle:
other: Polyethylene glycol PEG 400
Duration of exposure:
24h
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: There were no signs of systemic toxicity.
Gross pathology:
Effects on organs:
MACROSCOPIC FINDINGS: No macroscopic findings were noted.
Other findings:
Signs of toxicity (local):
No local effects noted.
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Information from migrated NONS file, as per inquiry number 06-2120077351-60-0000, permission to refer granted by ECHA.

Additional information

Acute oral toxcity

There is one acute oral toxicity study in the rat available.

In an acute oral toxicity study (EPA-guideline 798.1175 (based on Directive 92/69/EEC,B.1)/GLP), Sprague Dawley rats (5/dose/sex) were administered 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane in 0.5 % aqueous methylcellulose by gavage at doses of 2000, 3150 and 5000 mg/kg bw and observed for 14 days. All animals survived through the 14-day observation period. The body weight was within the normal range. Light colored feces were observed in all animals on day 1. With the exception of one female rat exhibiting decreased feces on day 10 and 11, the animals appeared normal. No findings considered treatment related were noted at necropsy. The LD50 (male/female) was >5000 mg/kg bw.

Acute dermal toxcity

There is one acute dermal toxicity study in the rat available.

In an acute dermal toxicity study (Directive 92/69 EEC, B.3/GLP), Wistar rats (5/dose/sex) were dermally exposed (semi-occlusive) to

3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane wetted in Polyethylene glycol PEG 400 at doses of 2000 mg/kg bw for 24 hours. There were no deaths as a result of treatment with the test article. The body weight gain of the animal was within the normal range of this strain and age. There were no signs of systemic toxicity and no local effects noted.. No macroscopic findings were noted. The LD50 (male/female) was >2000 mg/kg bw.

Both studies are suitable to use in the human health risk assessment.

Justification for classification or non-classification

Based on the available information in the dossier, the substance 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane (CAS No. 154862-43-8) does not need to be classified for acute toxicity or specific target organ toxicity - single exposurewhen the criteria outlined in Annex I of 1272/2008/EC are applied.