Registration Dossier

Administrative data

Description of key information

Acute oral toxicity (OECD 423): LD50 (rat, f) > 2000 mg/kg bw

Acute dermal toxicity (OECD 402): LD50 (rat, m/f) > 2000 mg/kg bw

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:
16 Apr - 13 May 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
HsdCpb:Wu
Sex:
female
Route of administration:
oral: gavage
Vehicle:
other: demineralized water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
piloerection, decreased motility, closed eyelids, hunched posture, narrowed palpebral fissure, poor reflexes, poor general condition, uncoordinated gait and abdominal and lateral position
Body weight:
no effects on weight gain
Gross pathology:
no findings
Other findings:
none

Dose (mg/kg bw) Toxicological results  Onset and duration of clinical signs  Onset of mortality
(1st) 2000 0 / 3/ 3 15´- 6h --- 
(2nd) 2000 0 / 3/ 3 15´- 6h --- 

Toxicological results:

number of dead animals / number of animals with clinical signs after treatment / number of animals treated

Additional detailed tables are attached below under 'Attached background material'.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
According to OECD guideline 423 the LD50 cut-off of 5000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5, of Regulation (EC) No. 1907/2006 (REACH).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test type:
other: acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
none: limit test
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
not influenced by treatment
Gross pathology:
no noticable gross pathological findings

Dose-response summary

Sex          Dose mg/kg bw/day       Toxicological result*       Occurrence of signs       Time of death       Mortality [%]

males       2000                              0 / 0 / 5                           --                                  --                        0

females    2000                              0 / 0 / 5                           --                                  --                        0

*: number of animals which died spontaneously and/or were sacrificed in moribund state / number of animals with signs of toxicity / total number of animals used per group

Additional detailed tables are attached below under 'Attached background material'.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The acute dermal toxicity is low with a LD50 value exceeding 2000 mg/kg bw in rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Section 8.5, of Regulation (EC) No. 1907/2006 (REACH).

Additional information

Oral acute toxicity

The acute oral toxicity of ethane-1,2-diol, propoxylated (CAS No.31923-84-9, EC No. 500-078-0) was investigated in a study conducted according to OECD guideline 423 under GLP conditions (rel.1-key, rat, OECD 423, Bayer Schering Pharma, 2009a, T6080152). In a first step, three female Wistar (HsdCpb:Wu) rats were administered 2000 mg/kg bw of the test substance formulated in deionised water (dose volume 10 mL/kg bw). The starting dose level was chosen as the one most likely to produce mortality. Since the first dosing did not result in any mortality, another three females were dosed with again 2000 mg/kg bw to confirm the findings of the first step. No mortality occurred in the second step. The clinical signs observed were piloerection, decreased motility, closed eyelids, hunched posture, narrowed palpebral fissure, poor reflexes, poor general condition, uncoordinated gait and abdominal and lateral position. All animals recovered 6 h after dosing and showed no further signs of toxicity until the end of the 14-day observation period. Based on the findings, the LD50 of ethane-1,2-diol, propoxylated was determined to be > 2000 mg/kg bw.

Dermal acute toxicity

A study according to OECD guideline 402 and following GLP conditions was performed to investigate the acute dermal toxicity of ethane-1,2-diol, propoxylated (CAS No.31923-84-9, EC No. 500-078-0) (rel 1-key, rat, OECD 402, Bayer Schering Pharma, 2009b, T7080153). Groups of 5 male and 5 female Wistar (HsdCpb:Wu) rats received a single dose of 2000 mg/kg bw of the unchanged test substance applied onto the skin under semi-occlusive conditions for 24 h. Animals were observed for 14 days post application. A dose of 2000 mg/kg body weight was tolerated by male and female rats without mortalities, clinical signs, effects on weight development and gross pathological findings. The dermal acute LD50 was, therefore, determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

The available data on oral and dermal acute toxicity with ethane-1,2-diol, propoxylated (CAS No.31923-84-9, EC No. 500-078-0) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.