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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Justification for type of information:
Justification for read across is detailed in the report attached to the IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to guideline
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:
no
Remarks:
Centre certificated ISO 9001 by National Accreditation Program (N. 98-1101)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- 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

ENVIRONMENTAL CONDITIONS
- 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

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

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
PREPARATION/ADMINISTRATION OF TEST SUBSTANCE:
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
Doses:
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.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality at 2000 mg/Kg bw was observed.
Clinical signs:
No abnormalities were observed during the test period
Body weight:
Normal body weight variation
Gross pathology:
No abnormalities were observed
Other findings:
No abnormalities were observed
Interpretation of results:
GHS criteria not met
Conclusions:
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
Dose descriptor:
LD50
Value:
2 000 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Justification for read across is detailed in the report attached to the IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline available
Principles of method if other than guideline:
The study report contains the limited information on the test conditions because the study has been performed in 1990. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 235 - 275 g
Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg
- For solids, paste formed: yes
Doses:
5 g/kg
No. of animals per sex per dose:
5 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
Without any clinical signs of intoxication.
Gross pathology:
No macroscopically observable changes were detected in the organs.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Not classified according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

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

For acute dermal toxicity:

Category 1: 0 < ATE <= 50 mg/kg bw

Category 2: 50 < ATE <= 200 mg/kg bw

Category 3: 200 < ATE <= 1000 mg/kg bw

Category 4: 1000 < ATE <= 2000 mg/kg bw

Based on the test result, the substance is to be considered as not toxic for acute oral and dermal exposure.