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Diss Factsheets

Administrative data

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
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
equivalent or similar to guideline
EU Method B.1 (Acute Toxicity (Oral))
according to guideline
other: Real Decree 363/1995 and Real Decree 1078/93
Principles of method if other than guideline:
Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation
GLP compliance:
Centre certificated ISO 9001 by National Accreditation Program (N. 98-1101)
Test type:
acute toxic class method
Limit test:
Details on test animals or test system and environmental conditions:
- Source: authorized provider.
- Health: rats were submitted to a sanitary control.
- Age at study initiation: young and healthy rats
- Housing: 3 rats for every cube of Makrolon (48 x 27 x 20 cm) by Tecniplast, with bed of woodchip. Each cube has been signed by label.
- Diet: free access to specific fodder for experimental rat, supplied by authorized provider
- Water: tap water ad libitum by Makrolon bottle
- Acclimatation period: 7 days

Before starting test each rat was marked by black pen on tail

- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 25
- Air changes (per hr): 15 air changes by pre-filtration of 5 µm
- Photoperiod (hrs dark / hrs light): 12/12 by timer

Materials used:
Balance: COBOS D 6000-SX
Vinyl/latex Gloves
Syringes of 1 and 2 ml

Route of administration:
oral: gavage
Details on oral exposure:
2000 mg of test substance were dissolved in 20 ml of water.
Administration: 2 ml/100 g of body weight. Forced administration by metallic cannula, after a fasting night.
Since 3 hours after administration, the regular diet was recovered
25, 200 and 2000 mg/Kg bw
No. of animals per sex per dose:
3 per 3 per dose
Control animals:
not specified
Details on study design:
- Administration: oral administration by metallic probe
- Duration of observation period following administration: 14 days
- Frequency of observations: In the first day frequent observations, and then, once every working day
- Sacrifice: yes by CO2 inhalation or cervical dislocation
- Necropsy performed: yes, macroscopic
- Body weight: performed at the start of the study, before substance administration, at 7 days after administration and at the end of the study.
- General examination: skin, fur, eyes, mucose, respiratory system, cardiovasculary system, central and periheral nervous system, somatomotor system and behaviour. A particular attention was given to tremors, convulsions, salivation, diarrhea, letargia, sleep and coma.
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortality at 2000 mg/Kg bw was observed.
Clinical signs:
other: No abnormalities were observed during the test period
Gross pathology:
No abnormalities were observed
Other findings:
No abnormalities were observed
Interpretation of results:
GHS criteria not met
LD50 oral rat > 2000 mg/Kg bw.
Executive summary:

The susbtance was tested for oral acute toxicity according to the Real Decree 363/1995, that is the transposition of Directive 67/548/EEC in Spanish legislation. The LD50 value is > 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the test result for acute oral toxicity, the tested substance is considered as not toxic for oral route with a LD50 > 2000 mg/kg.

Justification for selection of acute toxicity – oral endpoint
Test well reported

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be greater than 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.