Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

rat oral: LD50 > 7750 mg/kg bw

rat, inhalation: no data available  

rabbit, dermal: LD50 > 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no details on test substance, limited documentation
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: own breeding facility
- Weight at study initiation: 160 to 180 grams
- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 14/10
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
DOSAGE PREPARATION (if unusual):
Test substance was suspended with polyethylene glycol (PEG 400). Before treatment the suspension was homogenously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

VEHICLE
- Concentration in vehicle: 30 %

Doses:
4640, 6000, 7750 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
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 750 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days.
Gross pathology:
No substance related gross organ changes were seen.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of the test article in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg.
Executive summary:

The test substance was tested for acute toxicity in male and female rats in a study comparable to OECD 401 with restrictions (limited details, no body weight monitoring, no details on test substance). The test substance was dissolved in polyethylene glycol and administered by gavage to 5 rats per sex per dose (fasted overnight) in the following concentrations: 4640, 6000, 7750 mg/kg bw. No deaths occured and the LD50 was defined as greater than 7750 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days. They were submitted at random to a necropsy at the endof the observation period. No substance related gross organ changes were reported.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 750 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
author unknown, very brief, limited details, no necropsy
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2933 g (mean weight)
- Housing: 1 animal/cage
- Diet: Nafag Würfel Nr. 84

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-2
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 10/14
Type of coverage:
occlusive
Vehicle:
other: Gum arabic 1% in aquous solution (tap water)
Details on dermal exposure:
TEST SITE
- Area of exposure: 200-300 cm²
- Clipping of the fur

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with hand warm water and sponge
- Time after start of exposure: 24h
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: unknown
- Necropsy of survivors performed: no
- Other examinations performed: body weight
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
other: no data
Gross pathology:
no findings
Other findings:
no findings for skin
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

In the key study, groups of five fasted Tif: RAIf (SPF) rats per sex were given a single oral dose of the test substance (30%) in polyethylene glycol at doses of 4640, 6000, 7750 mg/kg bw and observed for 14 days. No mortalities occurred. Clinical signs were recorded for rats in all dosage groups 2 hours after substance administration like sedation, dyspnea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days. Necropsy performed with animals selected randomly did not show any gross organ changes. Based on the results of this study an oral LD50 (rat) greater than 7750 mg/kg bw was derived, the test substance is practically non-toxic in males and females.

This low oral toxicity potential was confirmed by three supporting studies. In the first supporting study, groups of fasted, Chinese hamsters (5/sex) were given a single oral dose of test substance in polyethylene glycol at a dose level of 3000 mg/kg bw and observed for 14 days. No mortalities occurred. Clinical symptoms like ruffled fur, dyspnea and curved body position were seen after 1 hour (fully reversible within 5 days). A decrease in body weight was reported after 7 days (non-reversible within 14 days). There were no treatment related necropsy findings. In two further acute toxicity studies single groups of CFE (SPF) rats (5/sex) and Swiss mice (5/sex) were given a single dose of test substance (25%) in gum arabic (1%) at a dose of 5000 mg/kg bw followed by an observation period of 8 days. No mortality occurred. Clinical signs like ruffled fur, ataxia, dyspnea and somnolence were detected.

Acute dermal toxicity:

In an acute dermal toxicity study one group of New Zealand white rabbits (3 males) were dermally exposed to the test substance (80%) in gum arabicum (1%)/water for 24 hours at a dose level of 2000 mg/kg bw followed by an observation period of 8 days. Besides reduction of body, weight no treatment-related effects (like clinical signs, necropsy findings) were seen. No mortalities occurred. Based on these results, a dermal LD50 (rabbit) > 2000 mg/kg bw was derived. The test substance is practically non-toxic based on the LD50 in males and females.

Acute inhalative toxicity:

One acute inhalation study conducted by IBT is available. In this study, five Sprague-Dawley rats per sex were exposed to an atmosphere containing the test article for 4 hours followed by a 14 day observation period. No mortalities occurred; The reported maximum concentrations of test material was 3.9 mg/m³. Considering the history of IBT (reporting of fake data), the reliability of these studies is questionable and an accurate Klimisch rating is impossible. Consequently, the study is rated with Klimisch 4. Based on the history of IBT, these studies can only be rated with Klimisch 4 (see above). However, since no further testing is necessary according to Annex VIII (8.5) of Regulation (EC) No 1907/2006 (reliable data on two other routes are provided) this inhalation study is disregarded.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral, dermal or inhalatory toxicity under Regulation (EC) No. 1272/2008.