Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

No adverse effects have been reported up to the limit dose regarding systemic repeated dose toxicity, toxicity to reproduction, genotoxicity, acute and local effects.

A recent GLP OECD 422 study in rats showed no adverse effects at the highest dose tested (i.e., 1000 mg/kg bw/day)). Doses included 100, 350, 600 and 1000 mg/kg bw/ day. Test substance-related blue discoloration/contents were observed macroscopically in the stomach, duodenum, jejunum, ileum, cecum, colon, and rectum of all test substance-administered groups at the primary necropsy, which correlated microscopically with blue contents. Blue matting of skin and tail were additionally noted macroscopically at the primary and recovery necropsies. The findings were attributed to the blue color of test substance and were considered to be nonadverse. No test substance-related differences in final body weights or organ weights were noted. There were no adverse test substance-related clinical observations or effects on mean body weights, body weight gains, and food consumption noted at any dosage level. Furthermore, there were no adverse effects on organ weights, clinical pathology parameters, thyroid hormones (males only) or macroscopic/microscopic examination in the F0 males and females at any dosage level. Therefore, the NOAEL for systemic toxicity was considered to be 1000 mg/kg/day.

In addition, a recent GLP OECD 423 Acute Oral Toxicity study in rats reported an LD50 > 2,000 mg/kg bw with no significant clinical effects and a recent GLP OECD 402 acute dermal toxicity study in rats reported an LD50 > 2,000 mg/kg bw with no significant clinical effects or irritation.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

No adverse effects have been reported up to the limit dose regarding systemic repeated dose toxicity, toxicity to reproduction, genotoxicity, acute and local effects.

A recent GLP OECD 422 study in rats showed no adverse effects at the highest dose tested (i.e., 1000 mg/kg bw/day)). Doses included 100, 350, 600 and 1000 mg/kg bw/ day. Test substance-related blue discoloration/contents were observed macroscopically in the stomach, duodenum, jejunum, ileum, cecum, colon, and rectum of all test substance-administered groups at the primary necropsy, which correlated microscopically with blue contents. Blue matting of skin and tail were additionally noted macroscopically at the primary and recovery necropsies. The findings were attributed to the blue color of test substance and were considered to be nonadverse. No test substance-related differences in final body weights or organ weights were noted. There were no adverse test substance-related clinical observations or effects on mean body weights, body weight gains, and food consumption noted at any dosage level. Furthermore, there were no adverse effects on organ weights, clinical pathology parameters, thyroid hormones (males only) or macroscopic/microscopic examination in the F0 males and females at any dosage level. Therefore, the NOAEL for systemic toxicity was considered to be 1000 mg/kg/day.

In addition, a recent GLP OECD 423 Acute Oral Toxicity study in rats reported an LD50 > 2,000 mg/kg bw with no significant clinical effects and a recent GLP OECD 402 acute dermal toxicity study in rats reported an LD50 > 2,000 mg/kg bw with no significant clinical effects or irritation.