Registration Dossier

Administrative data

Description of key information

Acute toxicity: via oral route

The LD50 valueof CJ305 was above 2000 mg/kg bw (OECD TG423).

Most azo dyes have dermal toxicity discriminating dose > 2000 mg/kg. The similar substances and the test substance reviewed fall into this category.

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 November 28, 2016 to February 24, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Species:
rat
Strain:
other: Crl:WI Wistar
Sex:
female
Details on test animals and environmental conditions:
- Source: Charles River Laboratories Research Models and Services
- Age at study initiation: 8 week old
- Housing: three animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5-6 days
- Photoperiod: 12-hrs light
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Distilled water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
three
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
CJ305 did not cause mortality.
Clinical signs:
All animals were observed that liquid faeces, reddish coloured faeces, reddish coloured urine on Day 0 and Day 1. From Day 2 up to the end of the observation period all animals were symptom-free.
Body weight:
Body weight gains of CJ305 treated animal were increased during the study.
Gross pathology:
No external observations and No internal observations were recorded. The observations of Organ and Tissue were not applicable.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
According to OECD 423 test method, the LD50 value of CJ305 was above 2000 mg/kg. Therefore, CJ305 was Category 5 or Unclassified based on GHS criteria.
Executive summary:

This test using the procedures outlined in the CiToxLAB Study Plan for 16/377-001P and OECD 423 (OECD, 2008). A total of 6 female Crl:WI rats were orally dosed with CJ305 in two dose steps of three animals each, at 2000 mg/kg bw for both Group 1 and Group 2. All animals in the two dose steps tolerated the test article well with increasing body weights and no mortality reported. The clinical signs observed that liquid faeces, reddish coloured faeces, reddish coloured urine on Day 0 and Day 1. From Day 2 up to the end of the observation period all animals were symptom-free. In absence of mortality, other significant clinical and gross signs of toxicity, these results place CJ305 in the GHS Category 5 or Unclassified, the LD50 value of CJ305 was above 2,000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Reliable assessment based on similar substances.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Limited exposure evisaged.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Based on reliable review of literature and assessment of similar sulphonated azo dyes. No further animal testing is justified.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Methods not always explicit in reviews, but OECD testing principles appear to have been followed in most cases.
GLP compliance:
not specified
Test type:
other: Review of various studies
Limit test:
no
Species:
rat
Sex:
male/female
Details on test animals and environmental conditions:
Mostly rat data, but dermal effects on guinea pigs and rabbits also examined (non-maximised sensitisation studies and dermal irritation)
Type of coverage:
not specified
Vehicle:
not specified
Doses:
Up to 2000 mg/kg
Control animals:
not specified
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality reported
Clinical signs:
Other than discolouration, no clinical signs
Gross pathology:
No adverse systemic effects reported.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on reliable review of literature and assessment of similar sulphonated azo dyes.
No further animal testing is justified.
Executive summary:
From assessment of similar sulphonated azo dyes, none are noted as being acutely toxic and there is no evidence of dermal absorption. From various data sources, it is considered unlikely that the substance will be acutely toxic by the dermal route. Most azo dyes have acute toxicity discriminating dose > 2000 mg/kg and the similar substances reviewed fall into this category.

 

The impact of lithium is not likely to impact on the toxicity when comparing with sodium salts as dermal toxicity of lithium substances are reported to be low and in view of the minimal % w/w content of lithium, this is not significant in the classification of toxicity.

 

Studies on guinea pigs and rabbits for sensitising and irritancy assessment have not revealed any evidence of adverse systemic effects. Only the maximised sensitising studies (ie injected) appear to give positive results, confirming low levels of dermal absorption. Discolouration of skin will occur and the colour is difficult to wash off.

 

It is not considered justifiable to perform further acute dermal toxicity testing on CJ305 in view of the similarity with other dyes assessed in this report. It should also be noted that some other registrations have indicated waivers for this endpoint.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
This class of substance considered to be of low toxicity and not likely to be absorbed dermally.

Additional information

Acute toxicity: via oral route

A total of 6 female Crl:WI rats were orally dosed with CJ305 in two dose steps of three animals each, at 2000 mg/kg bw for both Group 1 and Group 2. All animals in the two dose steps tolerated the test article well with increasing body weights and no mortality reported. The clinical signs observed that liquid faeces, reddish coloured faeces, reddish coloured urine on Day 0 and Day 1. From Day 2 up to the end of the observation period all animals were symptom-free. In absence of mortality, other significant clinical and gross signs of toxicity, these results place CJ305 in the GHS Category 5 or Unclassified, the LD50 value of CJ305 was above 2,000 mg/kg.

Acute dermal toxicity

From assessment of similar sulphonated azo dyes, none are noted as being acutely toxic and there is no evidence of dermal absorption. From various data sources, it is considered unlikely that the substance will be acutely toxic by the dermal route. Most azo dyes have acute toxicity discriminating dose > 2000 mg/kg and the similar substances reviewed fall into this category.

 

The impact of lithium is not likely to impact on the toxicity when comparing with sodium salts as dermal toxicity of lithium substances are reported to be low and in view of the minimal % w/w content of lithium, this is not significant in the classification of toxicity.

 

Studies on guinea pigs and rabbits for sensitising and irritancy assessment have not revealed any evidence of adverse systemic effects. Only the maximised sensitising studies (ie injected) appear to give positive results, confirming low levels of dermal absorption. Discolouration of skin will occur and the colour is difficult to wash off.

 

It is not considered justifiable to perform further acute dermal toxicity testing on CJ305 in view of the similarity with other dyes assessed in this report. It should also be noted that some other registrations have indicated waivers for this endpoint.

Justification for selection of acute toxicity – dermal endpoint

Based on reliable review of literature and assessment of similar sulphonated azo dyes.

No further animal testing is justified.

Justification for classification or non-classification