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Diss Factsheets

Administrative data

Description of key information

In a fixed dose procedure female rats received a single dose of 2000 (1 female) and 300 mg/kg bw (5 females) by gavage. Rats were observed for 14 days thereafter. The female at 2000 mg/kg bw died within one day after dosing showing reduced body weight, purple staining of the urine and abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. Females at 300 mg/kg did not show any effects on body weight, clinical signs and macroscopic investigations. The faeces of 4 of these females was purple stained. Based on these findings the oral LD50 of the substance is between 300 and 2000 mg/kg bw.

In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 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:
10 January 2017 to 1 february 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Strain: RccHan™:WIST
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 152-201 g
- Fasting period before study: overnight before dosing and 3-4 hours after dosing
- Housing: solid-floor polypropylene cages furnished with woodflakes (maximum 4/cage)
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED: 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: statring dose 300 mg/kg bw in absence of any information on toxicity
Doses:
300 mg/kg bw 1 female
2000 mg/kg bw 1 female
300 mg/kg bw 4 additional females
No. of animals per sex per dose:
at 2000 mg/kg bw 1 female; at 300 mg/kg bw 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality: twice daily (once in weekends)
clinical signs: 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days
bodyweight: day 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
NA
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
1 female at 2000 mg/kg bw on day 1
Clinical signs:
none observed at 300 and 2000 mg/kg bw
at 2000 mg/kg bw: purple staining of urine
at 300 mg/kg bw: black/purple staining of faeces 4/5 females
Body weight:
at 2000 mg/kg bw: decreased by ca 10% within one day
at 300 mg/kg bw within normal ranges
Gross pathology:
at 2000 mg/kg bw: abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine
at 300 mg/kg bwno abnormalities observed
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 of the substance is between 300 and 2000 mg/kg bw
Executive summary:

In a fixed dose procedure female rats received a single dose of 2000 (1 female) and 300 mg/kg bw (5 females) by gavage. Rats were observed for 14 days thereafter. The female at 2000 mg/kg bw died within one day after dosing showing reduced body weight, purple staining of the urine and abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. Females at 300 mg/kg did not show any effects on body weight, clinical signs and macroscopic investigations. The faeces of 4 of these females was purple stained. Based on these findings the oral LD50 of the substance is between 300 and 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw
Quality of whole database:
LD50 between 300 and 2000 mg/kg bw

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
Study period:
29 March 2017 to 28 April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
As the acute oral LD50 leads to classification, the acute dermal study cannot be waived.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain; RccHan:WIST
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Females nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 255-275 g; females 201-236 g
- Fasting period before study: none
- Housing: 1 male+ 1 females individually; 4 males + 4 females individually during exposure and 4/sex per cage during the rest of the test period in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: ca 10% of body surface
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes wiped with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied:2000 mg/kg bw (moistened with distilled water)

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 male + 1 female followed by 4 males + 4 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days (includes signs of irritation)
- Bodyweight: on day 1 7 and 14
- Necropsy of survivors performed: yes
Statistics:
NA
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:
one female did not gain weaight
Gross pathology:
no findings
Other findings:
No irritation observed. All animals showed staining of the skin at the test site up to day 4 and one female with scabs
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the substance is > 2000 mg/kg bw
Executive summary:

In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the available information the substance needs to be classified as harmful after oral exposure (H302, harmful if swallowed) according to Regulation (EC) No 1272/2008 (CLP)