Registration Dossier

Diss Factsheets

Administrative data

Description of key information

THPC (80%) was found to be corrisive in repeated dose studies in rabbits and rats. Testing of eye irritation/corrosion is considered not necessary.
Repiratory irritation potential has not been tested because of limited exposure in the workplace. Technical THPC (80%) is an liquid solution. THPC is ionic compound which cannot be inhaled other than by means of an aerosol. Under intended conditions of use the formation of an aerosol is not a realistic exposure scenario for men.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published data from a peer reviewed journal. Evaluated data from a reliable secondary source (US-CPSC).
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
dermal LD50 study, 24 h exposure
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
4084 mg/kg (body weight)
Duration of treatment / exposure:
24 hours
Observation period:
no data
Number of animals:
no data
Details on study design:
acute dermal toxicity of THPC in the albino rabbit
Irritation parameter:
other: erythema and edema
Basis:
other:
Reversibility:
no data
Remarks on result:
other: observation during dermal LD50 study
Irritant / corrosive response data:
Erythema and edema were observed after a 24-hour exposure of albino rabbits to 4084 mg/kg THPC (uncited data in NTP 1987; Ulsamer et al. 1980),
but no increase in mortalit was reported.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
Commercial material is corrosive to rabbit skin.
Executive summary:

THPC is corrosive to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Immediate skin irritation/corrosion is not observed after first/single contact but after 2 days redness becomes visible which develops badly. In an LD50-limit test, necrosis and scar formation after 14 days recovery period indicates potential for irreversible destruction of the skin. No conclusive data is available describing the dose and exposure time dependence of the effect. A single dermal exposure for 4 hours or less might be not corrosive but there is sufficient evidence from 24 hours or repeated dose exposure tests for classification THPC as corrosive.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin corr 1B, H314: Causes severe skin burns and eye damage.

STOT SE 3, H335 is considered not necessary because of limited exposure under expected normal handling and use.