Esterification products of 2,2-dimethylpropane-1,3-diol with n-heptanoic acid and n-octanoic acid and n-decanoic acid

Endpoint summary

Description of key information

Acute oral LD50 > 2000 mg/kg bw; based on read-across from supporting substance (structural analogue or surrogate).

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:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (analytical purity not reported)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no analytical purity reported

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:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 175 g (mean; males), 157 g (mean; females)
- Fasting period before study: animals were fasted 16 hours prior to administration and 3 hours after administration.
- Housing: 5 animals of the same sex per cage in Makrolon type III cages; bedding: soft wood granulate
- Diet: Altromin-Haltungsdiät, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 25 °C
- Humidity (%): 45 – 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% g/v
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed several times on the day of the application, and twice daily afterwards. Individual body weights were recorded 1 day before the dosing, on the day of the dosing, 48 hours, 7 days and 14 days after the application.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

males: full bladder in 1/5 animal; haemangioma of the left renal lymph node in 1/5 animals; mild hypoplasia of the right testis in 1/5 animals
females: high grade hydrometra and haemangioma of the left renal lymph node in 1/5 animal.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standar d test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Justification for type of information:

Please see attached justification for read across in Section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures, the substance does not have to be classified and has no obligatory labelling requirement for oral toxicity.