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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidelines and GLP, but not fully reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
the test substance was a similar material (aryl alkyl sulphonate) to CAS 70024-69-0
purity is stated as 35.1% active in oil

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus: Pressure spray

- Exposure chamber volume: 100 l

- System of generating particulates/aerosols: pressure spray

- Method of particle size determination: multi stage cascade impactor








TEST ATMOSPHERE

- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.2 microns S.d. 1.9
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
>= 4 h
Concentrations:
1.9 mg/l
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: bodyweight determined on day 1, 2, 3, 5, 8 and 15

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight
Statistics:
Statistical method not stated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.9 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: 95% CL not indicated.
Mortality:
Mortality did not occur in treated animals.
Clinical signs:
other: Clinical signs of toxicity included reduced activity, matted coat and closed eyes. On day 1, lacrimation, nasal discharge, salivation, rales, matted coat, hunched appearance, soft stools and closed eyes were observed in treated animals. These clinical sig
Body weight:
Several animals had very slight decreases in bodyweight on day 2, but recovered by day 5.
Gross pathology:
No treatment related effects were observed on necropsy.

Any other information on results incl. tables

Table 2: Concentrations, exposure conditions and number of evident toxicity per animals treated

 

Nominal

Conc. (mg/L)

Analytical Conc. (mg/L)

MMAD

µm

GSD

 

Number with evident toxicity (#/total)

Males

Females

Combined

 

 1.9

 4.2

 1.9

 5/5

5/5 

10/10 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mortality did not occur at doses of 1.9 mg/l. Therefore, the LC50 > 1.9 mg/L.
Executive summary:

In an acute inhalation toxicity study, groups of young adult Sprague Dawley rats (5/sex) were exposed by inhalation route for 4 hours via whole body exposure to petroleum derived calcium salts at concentrations of 1.9  mg/L. Animals then were observed for 14 days.

No mortality occurred in this limit test. Therefore, the LC50 > 1.9 mg/L.. This acute inhalation study is classified as acceptable. It satisfies the guideline requirement for an acute inhalation study in the rat.