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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Jun - 3 Aug 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
purity not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

1
Reference substance name:
Isooctadecanoic acid, monoester with propane-1,2-diol
EC Number:
269-027-5
EC Name:
Isooctadecanoic acid, monoester with propane-1,2-diol
Cas Number:
68171-38-0
Molecular formula:
not applicable, substance is UVCB
IUPAC Name:
2-hydroxypropyl 15-methylheptadecanoate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA Credo (L'Arbresle, France)
- Age at study initiation: 2 months
- Weight at study initiation: 190.2 +/- 3.2 g (males), 167.6 +/- 5.6 g (females)
- Fasting period before study: yes, for 16 h prior treatment
- Housing: 5 per box in makrolon boxes (46.5 x 31 x 19 cm) with soft wood sawdust.
- Diet: ad libitum, rat feed
- Water: tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 +/- 2.5
- Humidity (%): 52 +/- 8
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 Jun to 13 Jul 1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The product was administered undiluted.
Doses:
2000 mg/kg bw (2.15 mL/kg bw)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of mortality check: twice daily
- Frequency of weighing: D0 just prior treatment, D4, D7 and D14
- Necropsy of survivors performed: yes
- Clinical examinations: During the 3 hours following product administration, the animals were quasi continuously observed in order to note the clinical signs of toxicity.
During the following 14 days, a daily observation was made. Motor coordination, convulsions, motility, stereotypies, reflexes, breathing, piloerection, temperature, sweating, salivation, tremor, pupil size, eyelid opening, lacrimation, skin color, defecation, urine were recorded.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred during this study.
Clinical signs:
other: No abnormal clinical signs were seen. No changes in behavior were seen.
Body weight:
other body weight observations
Remarks:
All animals gained weight throughout the study.
Gross pathology:
No macroscopic lesions.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.