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EC number: 423-460-8 | CAS number: 3508-98-3 SALICYNALVA
Endpoint summary
Administrative data
Description of key information
- Oral LD50 is >2000 mg/kg bw in an OECD TG 420
- Dermal LD50 is >2000 mg/kg bw in an OECD 402
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The one study available is of adequate quality.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The one study available is of adequate quality.
Additional information
Acute oral toxicity
A study was performed to assess the acute oral toxicity of Salicynalva to the rat according to the fixed dose procedure, similar to OECD TG 420. Groups of ten fasted rats (five males and five females) were given a single dose by oral gavage of the test substance, as supplied, at dosages of 500 and 2000 mg/kg bodyweight. A further group was treated using the test substance formulated in distilled water at a dosage of 50 mg/kg body weight. All animals surviving treatment were killed and examined macroscopically on Day 15, the end of the observation period. One male at 500 mg/kg and two males and two females at 2000 mg/kg died during the study. All deaths occurred between 24 and 48 hours of dosing. A slight body weight loss was recorded for some decedents. Macroscopic examination revealed congestion in the majority of major organs and tissues. Clinical signs of reaction to treatment were confined to piloerection in rats dosed at 50 mg/kg. Among rats treated at 500 and 2000 mg/kg, piloerection, abnormal body carriage, abnormal gait, decreased respiratory rate, pallor of the extremities, increased salivation, walking on toes and unsteadiness were observed. In addition, lethargy, increased urine production and hair loss were evident among rats dosed at 2000 mg/kg only. Recovery of surviving rats was complete in all instances by Day 9 with the exception of hair loss which had resolved in the majority of surviving rats dosed at 2000 mg/kg by Day 10 or Day 11 but persisted in one surviving rat dosed at 2000 mg/kg through to the end of the observation period (Day 15). Slightly low body weight gains were recorded on Day 8 for three males and one female dosed at 2000 mg/kg bodyweight; these animals achieved the anticipated bodyweight gains on Day 15. All other surviving animals achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The LD50 of Salicynalva when administered orally to rats was established to be > 2000 mg/kg bodyweight.
Acute dermal toxicity
An OECD TG 402 study was performed to assess the acute dermal toxicity of Salicynalva to the rat. A group of ten rats (five males and five females) was given a single occlusive dermal application of the test substance, as supplied by the sponsor and administered at a dosage of 2.0 g/kg bodyweight, no vehicle was used. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. With the exception of a residual black staining from the test substance on the treatment sites of some animals, there were no other dermal changes observed in any animal throughout the dose period (scores of zero for erythema and oedema were recorded for all animals). Slightly low bodyweight gains were recorded for three males and three females on Day 8, with a similar trend noted for one male and two females on Day 15. In addition, two females showed a slight bodyweight loss on Day 8 and one female showed no bodyweight gain on Day 15. The remaining animals achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal dermal dose to rats of Salicynalva was found to be greater than 2000 mg/kg bodyweight.
Justification for classification or non-classification
The substance does not have to be classified for Acute oral toxicity according to EU CLP (EC No. 1272/2008 and its amendments) as the observed LD50 exceeds 2000 mg/kg bw. However, Salicynalva has a harmonized classification as H302 in table 3 of Annex VI of CLP for this endpoint.
The substance does not have to be classified for Acute dermal toxicity according to EU CLP (EC No. 1272/2008 and its amendments)
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