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Administrative data

Description of key information

rat oral LD50 = 161 mg/kg (NTP 1987)
rat dermal LD50 > 1500 mg/kg bw (Ulsamer 1980)
rabbit dermal LD50 = 281 mg/kg (Am.Cyanamid 1975/CPSC 2001)
inhalation LC50 (test waived: corrosive + limited exposure)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Published test report from National Toxicology Program (US). Evaluated data from a reliable secondary source (US-CPSC).
Principles of method if other than guideline:
see attached tables (results)
GLP compliance:
not specified
Remarks:
NTP study
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were housed five per cage. Feed and water were avaliable ad libitum.
Route of administration:
oral: gavage
Vehicle:
water
Doses:
75, 150, 300, 600, 1200 (mg/kg bw)
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
Spearman-Karber
Sex:
male
Dose descriptor:
LD50
Effect level:
185 mg/kg bw
Based on:
act. ingr.
95% CL:
141 - 242
Sex:
female
Dose descriptor:
LD50
Effect level:
161 mg/kg bw
Based on:
act. ingr.
95% CL:
115 - 224
Mortality:
All male and female rats that received 600 or 1200 mg/kg THPC and all males that received 300 mg/kg THPC were dead by day 2.
Clinical signs:
Surviving rats of each sex that received 150 mg/kg had reddish fluid around the nostrils by day 3 and labored breathing.
Body weight:
final weights were not recorded.
Gross pathology:
Necropsies were not performed.
Interpretation of results:
Category 3 based on GHS criteria
Remarks:
Migrated information: rat oral LD50 = 161 mg/kg
Conclusions:
rat oral LD50 = 161 mg/kg
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
161 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published data from 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
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
albino rabbits
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
24 hours
Doses:
4,084 mg/kg (body weight)
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
not applicable: no deaths occourred.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 084 mg/kg bw
Based on:
test mat.
Mortality:
no deaths (at limit dose)
Clinical signs:
varying degrees of erythema and edema of the (integumentary system) treated skin.
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 (rabbit) is greater then 4084 mg/kg bw.
Executive summary:

acute dermal LD50 (rabbit) > 4084 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
281 mg/kg bw

Additional information

Justification for classification or non-classification

Acute Tox 3, H301 Toxic if swallowed

Acute Tox 3, H311 Toxic in contact with skin