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Administrative data

Description of key information

Oral toxicity: LD50 > 2000 mg/kg bw
Dermal toxicity: 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
Study period:
From 20 march to 10 april 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Poory details
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
no
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: unspecified
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
Dose of test material was administrated as a suspension in arachis oil BP at a dose level of 2000 mg/kg body weight
Doses:
Single oral dose of 2000 mglkg,
No. of animals per sex per dose:
4 females
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes; all animals were subjected to gross necropsy.
- Other examinations performed: Clinical signs and body weight development were monitored during the study.


Sex:
female
Dose descriptor:
discriminating dose
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Estimated
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Other findings:
No abnormalities were noted at necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System Category - Unclassified).
The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat (SPL Standard Test Method 518.04). The method followed the OECD Guidelines for the Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted l7 December 2001). The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System Category - Unclassified)

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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Few details available on test procedures.
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Strain:
Wistar
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to European Union legislation substance of low toxicity (LD50 >2O0O mg/kg b.w.) is not classified to the class of toxicity based on the strength of toxicity in acute exposure conditions.
Executive summary:

According to European Union legislation, substance of low toxicity (LD50 >2O0O mg/kg b.w.) is not classified to the class of toxicity based on the strength of toxicity in acute exposure conditions.

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

Additional information

Direct Red 23 (DR23) is not toxic by oral, dermal and inhalation route. Studies available all confirm that DR23 is not toxic until very high dose.

Acute oral

In all studies, is not identified a 50-letal dose; nevertheless all confirm that DR23 is not toxic at limit fixed for classify in CLP regulation.

Acute inhalation

No study available

Acute dermal

In all studies is not identified a 50-letal dose. The Boruta study (Boruta, 1997) reported an LD50 > 2000 mg/kg tested on DR23. The other studies have been tested on some dyes, structural analogues to DR23. Also in these case has not been identified a limit dose, but all confirm that DR23 is not toxic until high doses, far from limit fixed for classify in CLP regulation.



Justification for selection of acute toxicity – oral endpoint
Study defines a LD50

Justification for selection of acute toxicity – dermal endpoint
Study on Direct Red 23

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) Direct Red 23 is not classified for Acute toxicity.