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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute mammalian toxicity in rats, exposed by the oral (gavage), inhalation and dermal routes.
LD50 (oral): > 5000 mg/kg bw
LC50 (inhalation): > 1.9 mg/L air
LD50 (dermal): > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Based on the available study data, this dataset is considered to be sufficiently reliable for classification purposes.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
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.
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.

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 
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Based on the available study data, this dataset is considered to be sufficiently reliable for classification purposes.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Based on the available study data, this dataset is considered to be sufficiently reliable for classification purposes.

Additional information

During exposure to the substance and read-across substances via the oral, dermal and inhalation routes, only minor incidences of mortality were observed and never at a rate considered to be significant when dosing levels were at or below the volumes specified below. Where significant mortality has been observed, this was observed at dose levels significantly higher than those specified below and thus beyond the limits of classification. The limit values expressed below are, therefore, considered appropriate.

LD50 (oral): > 5000 mg/kg bw

LC50 (inhalation): > 1.9 mg/L air

LD50 (dermal): > 5000 mg/kg bw


Justification for selection of acute toxicity – oral endpoint
The acute oral endpoint has been addressed on a weight of evidence basis to several read-across substances using the category approach.
All read-across studies were performed according to standardised guidelines and under GLP conditions, with the exception of the studies designated “acute oral-6” and “acute oral-7” which were not performed to GLP, and with the exception of the study designated “acute oral-10” which was not performed to a standardised guideline or under GLP conditions.
Accordingly these studies have been assigned reliability scores of 2 (reliable with restrictions) in line with the principles of Klimisch et al. (1997).
A study using the substance to be registered has also been provided. Since the study was presented as a short abstract, with insufficient reporting of the methodology and experimental conditions, it has been assigned a reliability score of 4 in line with the principles of Klimisch et al. (1997) and has been used as part of the weight of evidence approach to support non classification of this substance.

Justification for selection of acute toxicity – inhalation endpoint
The acute inhalation endpoint has been addressed in the key study using read-across to petroleum derived calcium salt overbased. The study was performed according to OECD guidelines and under GLP conditions. This study was assigned a reliability score of 2 (reliable with restrictions) in line with the principles of Klimisch et al. (1997). While there is an inhalation study on the test substance itself, the concentration administered to the rats is not defined. Therefore, the read across study was deemed more reliable. No mortalities were observed in either study.
A supporting study using the substance to be registered has also been provided. Since the study was presented as a short abstract, with insufficient reporting of the methodology and experimental conditions, it has been assigned a reliability score of 4 in line with the principles of Klimisch et al. (1997) and has been used to support the findings of the key study.

Justification for selection of acute toxicity – dermal endpoint
The acute dermal endpoint has been addressed on a weight of evidence basis using several read-across substances. These studies were performed according to OECD guidelines and under GLP conditions and have been assigned reliability scores of 2 (reliable with restrictions) in line with the principles of Klimisch et al. (1997).
A supporting study using the substance to be registered has also been provided. Since the study was presented as a short abstract, with insufficient reporting of the methodology and experimental conditions, it has been assigned a reliability score of 4 in line with the principles of Klimisch et al. (1997) and has been used as part of the weight of evidence approach to support non classification of this substance.

Justification for classification or non-classification

Based on the available data, the substance is considered to be not classified as acutely toxic, via the oral, inhalation and dermal routes in accordance with Regulation (EC) No. 1272/2008.