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Administrative data

Description of key information

Acute toxicity studies with AITC have been performed by oral, dermal and inhalation routes of exposure.

The acute LD50 of AITC by oral route is estimated to be 425.4 mg/kg bw in rats.

The acute LD50 of AITC by dermal route was between 200 and 2,000 mg/kg bw in rats.

The acute LC50 of AITC by inhalation route was between 0.206 and 0.508 mg/L/4h in rats.

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
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: gavage
Doses:
175, 55, 175, 550, 2000, 550, 2000, 550 mg/kg bw
No. of animals per sex per dose:
8
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
425.4 mg/kg bw
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the conditions of this study, the acute LD50 of IR9804 is estimated to be 425.4 mg/kg bw (based on maximum likelihood and an assumed sigma of 0.5) in female rats with a 95% PL (Profile-Likelihood based confidence interval) Confidence interval of 0 mg/kg (lower) to greater than 20,000 mg/kg (upper).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
425.4 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
not specified
Mass median aerodynamic diameter (MMAD):
>= 1.67 - <= 3.21 µm
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.05, 0.5 mg/L
No. of animals per sex per dose:
10 (5 males and 5 female)
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.206 - < 0.508 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
An acute inhalation toxicity test was conducted with rats to determine the potential for IR9804 to produce toxicity from a single exposure via the inhalation (nose-only exposure) route. Under the conditions of this study, the 4-hour exposure acute inhalation LC50 of the test substance (calculated as a Time Weighted Average) appears to be between 0.206 and 0.508 mg/L in male and females rats.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
206 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The appropriate amount of test substance (200 or 2,000 mg/kg bw) was applied evenly over a dose area of approximately 10% of the body surface and covered with a gauze pad. After 24h of exposure to the substance, the pads were removed and the test sites were gently cleansed of any residual test substance.
Duration of exposure:
24h
Doses:
200 or 2,000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
200 mg/kg bw: 0/10
2,000 mg/kg bw: 9/10
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
An acute dermal toxicity test was conducted with rats to determine the potential for IR9804 to produce toxicity from a single topical application. Under test conditions of this study, the single dose acute dermal LD50 of the test substance is between 200 and 2,000 mg/kg bw of body weight in male and female rats.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
200 mg/kg bw

Additional information

Justification for classification or non-classification

According to the available data, AITC is classified as:

Acute Tox. 4, H302

Acute Tox. 3, H311

Acute Tox 2, H330