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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 SEP 1982 to 27 OCT 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (MMAD not calculated, no necropsy performed, no observation on the weekends, individual raw data not included in report, only 6 males/group)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
- acute inhalation toxicity (4 h exposure)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 226 to 250 g
- Housing: stainless steel wire mesh cages (8" x 8" x 14") in pairs
- Diet: Purina certified chow #5002; ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates: Dust atmosphere of the test item was generated with a vertical two-stage glass generator consisting of a dust reservoir and a cyclone elutriator. An electric steel motor and steel rod with plastic paddles agitated dust in the generator. Air introduced at the reservoir carried dust particles upward to the elutriator. Additional houseline air carried airborne dust into the chamber.

TEST ATMOSPHERE
- Brief description of analytical method used: Samples from chamber were analyzed at 30-minute intervals. Calibrated volumes of test atmosphere were passed through preweighed glass fiber filters (Gelman Type AE, 25 mm) and atmospheric concentrations determined from filter weight gain. Airborne particle size measurements were obtained using Sierra 8-stage cascade impactor.

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
at concentration of 3.1 mg/L: 21 % have an aerodynamic diameter < 13 µm
at concentration of 2.6 mg/L: not determined
at concentration of 2.4 mg/L: not determined
at concentration of 1.6 mg/L: 17 % have an aerodynamic diameter < 13 µm
at concentration of 1.5 mg/L: 12 % have an aerodynamic diameter < 13 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not calculated


Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric measurement
Duration of exposure:
4 h
Concentrations:
1.5, 1.6, 2.4, 2.6, 3.1 mg/L
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (already one week before treatment, but the weekends excepted)
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 3.1 mg/L air (analytical)
Remarks on result:
other: no animals died within the 14 day observation period; exposure concentration of 3.1 mg/L corresponds to about 0.65 mg/L respirable dust (21% of dust particles had an aerodynamic diameter < 13 µm)
Mortality:
- no deaths occurred
Clinical signs:
- after exposure all animals had red stained fur
Body weight:
- immediately after exposure mild but transient weight loss but resumed a normal weight gain rate two days later
Gross pathology:
- not performed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP Regulation
Conclusions:
In an acute inhalation toxicity test male rats were exposed to dust concentrations up to 3.1 mg/L test item for 4 hours. Under the conditions tested no animal died during a 14 day observation period, resulting in a LC50 value of > 3.1 mg/L (corresponding to 0.651 mg/L respirable test item).
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male rats. They were exposed to 3.1 mg test substance per litre for 4 h. The test atmosphere contained only about 21% particles with an aerodynamic diameter (corresponding to 0.651 mg test item of respirable size). All animals survived the 14 day observation period, resulting in a LC50 value of > 3.1 mg/L (corresponding to 0.651 mg/L respirable test item) for the inhalation of dust.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008.