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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Acute oral toxicity: Oral LD50 > 5000 mg a.i./kg bw; OECD TG 401, rat; oral: gavage; RL1, GLP

 

Acute dermal toxicity: LD50 expected to be > 2000 mg/kg bw; no testing required

The study need not be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin. This is supported by experimental data for a similar substance, proving a very low dermal penetration rate of 0.01 %.

 

Inhalation: no relevant route of exposure + no acute intrinsic toxicity expected; no testing required

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
Study period:
07 Dec 1989 - 03 Jan 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, USA
- Weight at study initiation: 211-287 g
- Housing: 5 per cage in wire mesh suspension cages
- Diet: PURINA Laboratory Chow, ad libitum (fasted overnight prior to dosing)
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.2 mL/kg bw
Doses:
5000 mg/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 observations: animals were observed at least twice daily during the study study period. Individual body weights were determined on study initiation, Day 7 and Day 14 (study termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured.
Clinical signs:
No treatment-related changes.
Body weight:
No treatment-related changes.
Gross pathology:
No treatment-related changes.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
OECD guideline study, no deviations, GLP

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available data, D-Glucose reaction products with alcohols C16-C18 does not have to be classified and has no obligatory labelling requirement for acute oral, dermal or inhalation toxicity according to Regulation (EC) No 1272/2008.