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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
OECD 420 method reference not mentioned but similar protocole
equivalent or similar to guideline
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
Test type:
fixed dose procedure
Limit test:
Specific details on test material used for the study:
Sample NIK-242 , batch no. 6, 8, 9, 10
from hizuoka-ken Agriculture' Co-operative Association for Laboratory Animais
Details on test animals or test system and environmental conditions:
- assigned randomly
- initial body weights: not stated;
- age : 6 weeks old at the start of administration
- diet: radiologically sterilized solid chow (CE-2, Crea Japan, Inc.); food and water ad libitum
Route of administration:
oral: gavage
not specified
8.0, 9.5, 11.3, 13.5, and 16.0 g/kg for both sexes
No. of animals per sex per dose:
6/sex/dose group/treatment
Control animals:
Details on study design:
Dosing : 1 day
Observations: 14 days. Continuous monitoring for 5 hours alter dosing, the morning of the next day, then daily thereafter body weights recorded just prior to and 1, 3, 7, and 14 days alter dosing

Pathology observations : Gross examinations were performed at necropsy and on rats dying during the study; ail organs and tissues with abnormalities and those tissues from 1 or 2 groups of animais where mortality was near 50% were fixed in 10% buffered formalin and stained with H-E; at a minimum, the following tissues were examined: brain, thymus, heart, lungs, liver, spleen, pancreas, kidneys, adrenals, testes, ovaries, uterus, stomach, small intestine, colon, mesenteric lymph node, and bone marrow; histopathological examinations of the tissues were conducted for representative cases
LD„ and the 95% confidence intervals were calculated from cumulative number of deaths for 14 days by the probit method or van der Waerden's area method
Preliminary study:
Key result
Dose descriptor:
Effect level:
ca. 13 500 mg/kg bw
Based on:
test mat.
Key result
Dose descriptor:
Effect level:
ca. 13 100 mg/kg bw
Based on:
test mat.
males: 11.3 g/kg (1/6), 13.5 g/kg (3/6), 16.0 g/kg (6/6)
females: 13.5 g/kg (5/6), 16.0 g/kg (5/6)
Clinical signs:
In males, hypokinesis, oligopnea, and blepharoptosis appeared immediately following dosing in the 13.5 g/kg and higher dose groups and within 5 to 15 minutes in the lower dose groups. A transparent mucous¬like substance and watery faeces occurred 15 minutes alter dosing, and oily hair coats 30 minutes alter dosing, at ail doses tested. In males that died, a lack of response to sound, recumbency, abnormal respiration, lacrimation, cyanosis and a cold sensation in the skin were observed 30 minutes to 1 hour alter dosing. Death was due to cardiac arrest following respiratory arrest. In survivors, symptoms began to disappear in 1 or 5 hours. In females, symptoms were generally the same as in males, but appeared 5 minutes alter administration.
Body weight:
No decrease in animal weight after dosing. A steady increase in weight gain was seen in ail treated groups throughout the remainder of the study.
Gross pathology:
At necropsy, in animais which died, subdural haemorrhage, and congestion were observed. Some decedent animais showed evidence of thymic haemorrhage. In all treatment groups, decedent animais also showed dilatation and cytoplasmic vacuolization of the renal tubules. Surviving animais in ail treatment groups showed no gross or histopathological abnormalities when compared to controls
Interpretation of results:
GHS criteria not met
LD50 for erythritol in an assay comparable to OECD 420 method: 13.1 g/kg in males and 13.5 g/kg in females
Executive summary:

LD50 for erythritol in an assay comparable to OECD 420 method: 13.1 g/kg in males and 13.5 g/kg in females

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
13 100 mg/kg bw

Additional information

Justification for classification or non-classification

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