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Administrative data

Description of key information

HPMA is of a low order of acute oral toxicity in studies in rats and of a low order of acute dermal toxicity in studies in rabbits.

No acute inhalation toxicity test data are available for HPMA. Taking into account the low vapour pressure, inhalation is not a relevant route of exposure. The low order of toxicity of HPMA in acute oral and dermal tests would indicate that this material has a low order acute toxicity following inhalation exposure.

Taking into account the low vapour pressure and saturated vapour concentration of HPMA, inhalation is not a relevant route of exposure as confirmed by actual workplace concentrations (see attachment in IUCLID dataset chapter 13 Assessment reports). Potentially toxic concentrations cannot be reached due to the low vapour pressure.

MW

VP

Saturated vapour concentration @20°C

HPMA

144.168 mg/mol

0.11 hPa@ 20 °C

109 ppm/ 650 mg/m³

 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Rats given a single oral dose of HPMA of up to 2000 mg/kg survived exposure. The only clinical symptom of intoxication was salivation in a few animals administered the 2000 mg/kg dose. This study was compliant with OECD 401 and was assigned a Klimisch rating of 1, reliable without restriction.

The dermal LD50of HPMA in rabbits was determined to be > 5000 mg/kg. This study (Rohm and Haas 1982) was assigned a Klimisch rating of 2, reliable with restriction. No clinical symptoms of intoxication were noted. Animals’ skin presented with erythema but no edema. Other available studies were reviewed and judged to be not reliable or not assignable.

No acute inhalation toxicity test data are available for HPMA. Taking into account the low vapour pressure and saturated vapour concentration of the two chemicals, inhalation is not a relevant route of exposure as confirmed by actual workplace concentrations (see attachment in IUCLID dataset chapter 13 Assessment reports). Potentially toxic concentrations cannot be reached due to the low vapour pressure (0.11 hPa @ 20°C; see also category document, chapter 5.3.1.2).

Conclusion

HPMA had of a low order of acute oral toxicity in studies in rats. HPMA had a low order of toxicity in rabbits. No acute inhalation toxicity test data are available for HPMA, but none are needed as HPMA has a low acute toxicity by oral and dermal routes. The low order of toxicity of HPMA in acute oral and dermal tests would indicate that this material has a low order of acute toxicity following inhalation exposure.

Justification for classification or non-classification

The oral LD50 of HPMA in rats was determined to be >2000 mg/kg. The dermal LD50 in rabbits was determined to be > 2000 mg/kg.

Based on the LD50 values, HPMA is not classified for acute toxicity.

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