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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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

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

Additional information

Oral:

An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for Spectrace™MD-810 Marker (Solvent Free) to produce toxicity from a single dose via the oral route. All animals survived exposure to the test substance and gained body weight during the study. Following administration, all animals had blue staining at the base of the tail, and one animal exhibited facial staining. However, these symptoms cleared by Day 3, and along with the other animals, appeared active and healthy for the remainder of the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Under the conditions of this study, the acute oral LD50 of the test substance is greater than 2,000 mg/kg of body weight in female rats. Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the EEC Directive 67/548/EEC), Spectrace MD-810 Marker (Solvent Free) would not be classified and has no obligatory labelling requirement.

Dermal:

An acute dermal toxicity test was conducted with rats to determine the potential for Spectrace® MD-810

Marker (Solvent Free) to produce toxicity from a single topical application. Under the conditions of this

study, the single dose acute dermal of the test substance is greater than 2,000 mg/kg of body weight in

male and female rats. Classification according to HMIS, EPA, EEC, and WHMIS are presented in Table

4.

Two thousand milligrams per kilogram of body weight of the test substance was moistened with distilled

water and applied to the skin of ten healthy rats for 24 hours. The animals were observed for mortality,

signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were

recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all

animals at terminal sacrifice.

All animals survived, gained body weight, and appeared active and healthy. There were no signs of gross

toxicity, dermal irritation, adverse pharmacologic effects or abnormal behavior. No gross abnormalities

were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Justification for classification or non-classification

In an acute oral and dermal study both endpoints contained an LD50 value >2,000 mg/kg with no mortality or gross abnormalities observed.