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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.