7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol

Endpoint summary

Description of key information

Both of the acute oral toxicity studies show no mortality at the limit dose of 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

HanBrl: Wistar (SPF) female rats3 animals per group6 total female ratsAge when treated: 12 weeks

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Administered undiluated via oral gavage at a volume of 1.82 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

two separate groups of 3 female rats (6 rats total) were treated with 2000 mg/kg of the test material via oral gavage (undiluted). The animals were observed for 14 days post expsoure.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality at limit dose of 2000 mg/kg

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No macroscopic findings were recorded at necropsy.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

There was no mortality in any of the test animals at the limit dose of 2000 mg/kg bw. The substance is not considered to be acutely toxic via oral gavage.

Executive summary:

There was no mortality in any of the test animals at the limit dose of 2000 mg/kg bw. The substance is not considered to be acutely toxic via oral gavage.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Method:Oral gavage, using plastic feeding tubes.Frequency:Single dosage on Day 1.Dose level (volume):2000 mg/kg (1.833 mL/kg) body weight.Dose volume calculated as dose level (g/kg) / specific gravity.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitumrequencySingle dosage on Day 1 of 2000 mg/kg (1.833 mL/kg) body weight calculated as dose level (g/kg) / specific gravity.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality.

Mortality:

None.

Clinical signs:

other: Hunched posture and/or piloerection were noted for all animals on Days 1 and 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

LD50 > 2000 mg/kg bw based on no mortality at limit dose of 2000 mg/kg bw.

Executive summary:

This limit dose acute study run with 3 female rats dosed at 2000 mg/kg bw and 3 female control rats showed no mortality and only transient effects, hunched posture and/or piloerection, during Days 1 and 2. There were no lasting effects from the single exposure to body weight or other gross signs of toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

There are two equally reliable, guideline, acute oral studies on the two major commercial products manufactured under this substance.

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

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

SpeciesRat, Wistar strain, Crl:WI (Han) (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC).Source: Charles River Deutschland, Sulzfeld, Germany.Number of animals:5 males and 5 females (females were nulliparous and non-pregnant).Age and body weight:Young adult animals (approx. 10 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.ConditionsEnvironmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study. AccommodationIndividually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm).DietFree access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany). WaterFree access to tap water. Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

ClippingOne day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.Application:The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.Frequency:Single dosage, on Day 1.Dose volume calculated as dose level (g/kg) / specific gravity.Application period:24 hours, after which dressings were removed and the skin cleaned of residual test substance using tap water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

ConditionsEnvironmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study. AccommodationIndividually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm).DietFree access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany). WaterFree access to tap water. Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

None

Clinical signs:

other: Hunched posture and/or chromodacryorrhoea were noted for three animals between Days 2 and 6. General erythema, scales and/or scabs were seen on the treated skin-area of six animals during the observation period.

Gross pathology:

Red-brown discolouration of the thymus was found in one animal. Macroscopic examination of the other animals did not reveal any abnormalities.

Interpretation of results:

practically nontoxic

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Dermal LD50 >2000 mg/kw bw. No mortality at limit dose.

Executive summary:

Dermal LD50 >2000 mg/kw bw. No mortality at limit dose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
Both studies are equally reliable, with a reliability of 1.

Justification for classification or non-classification

The data indicate that tris dipropylene glycol is not acutely toxicity and does not meet the criteria for classification.