Erythritol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

OECD 434 method reference not mentioned but similar protocole

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1997

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Acute subcutaneous study

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Erythritol

EC Number:

205-737-3

EC Name:

Erythritol

Cas Number:

149-32-6

Molecular formula:

C4H10O4

IUPAC Name:

butane-1,2,3,4-tetrol

impurity 1

Reference substance name:

unknown impurities

IUPAC Name:

unknown impurities

Specific details on test material used for the study:

Sample NIK-242 , batch no. 6, 8, 9, 10

Test animals

Species:

rat

Strain:

Wistar

Remarks:

from hizuoka-ken Agriculture' Co-operative Association for Laboratory Animais

Sex:

male/female

Administration / exposure

Details on dermal exposure:

subcutaneous injection in the back

Doses:

doses of 9.5, 11.3, 13.5, 16.0 g/kg for both sexes

No. of animals per sex per dose:

6/sex/dose group/treatment

Control animals:

not specified

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 anima
is where mortality was near 50% were fixed in 10% buffered formalin and stained with H-E; at a mini
mum, the following tissues were examined: brain, thymus, heart, lungs, liver, spleen, pancreas, kid
neys, adrenals, testes, ovaries, uterus, stomach, small intestine, colon, mesenteric lymph node, and
bone marrow; histopathological examinations of the tissues were conducted for representative cases

Statistics:

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

Results and discussion

Preliminary study:

none

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 16 000 mg/kg bw

Based on:

test mat.

Mortality:

males 16.0 g/kg (3/6) and females 16 g/kg (2/6)

Gross pathology:

At necropsy, in animais which died, subdural haemorrhage, and congestion were observed. Som
e decedent animais showed evidence of thymic haemorrhage. In all treatment groups, decedent
animais also showed dilatation and cytoplasmic vacuolization of the renal tubules. Surviving anim
ais in ail treatment groups showed no gross or histopathological abnormalities when compared to
controls

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 for erythritol by subcutaneous route > 16g/kg in rats

Executive summary:

LD50 for erythritol by subcutaneous route > 16g/kg in rats