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Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: LD50: 1030 mg/kg bw (OECD 425; GLP compliant)

No acute dermal toxicity study is available, thus the acute dermal toxicity will be addressed with existing data on the dissociation products strontium and neodecanoate. Signs of acute dermal toxicity are not expected for strontium neodecanoate, since dermal absorption of the moiety strontium is low and the moiety neodecanoate have not shown signs of acute dermal toxicity in experimental testing (LD50 > 2000 mg/kg).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-09-30 to 2015-10-26
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
according to guideline
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
adopted 2008-10-03
GLP compliance:
yes (incl. QA statement)
signed 2014-05-14
Test type:
up-and-down procedure
Limit test:
other: Crl: CD(SD)
Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at dosing: approx. 8 weeks
- Weight at first dosing: 169 - 184 g
- Fasting period before study: feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum. Food was withheld to up to 3 - 4 hours post dosing.
- Housing: during the 14-day observation period the animals were kept individually in MAKROLON cages (type III plus); Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages.
- Diet: Commercial ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 adaptation days

- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity: 55% ± 15% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
polyethylene glycol
Details on oral exposure:
- Source: SIGMA-ALDRICH Chemie GmbH, 82024 Taufkirchen, Germany
- Justification for choice of vehicle: the vehicle is known for its low toxicity and provided test item suspensions that could be administered orally.
- Lot/batch no.: BCBN5570V


Strontium neodecanoate was suspended to the appropriate concentration in the vehicle.

1) Limit Test at 5000 mg/kg:
A dose of 5000 mg strontium neodecanoate/kg bw was tested in one animal. As this animal died prematurely the main test was conducted to determine the LD50.
2) Main test:
Dosing was initiated at 175 mg/kg bw and continued using a progression factor of approx. 3.2. The resulting sequence was 175, 550, 1750, 550, 1750, 550 and 1750 mg/kg bw. Each dose level was conducted with one female rat.
175, 550, 1750, and 5000 mg/kg bw
No. of animals per sex per dose:
175 mg/kg bw: 1 female rat
550 mg/kg bw: 3 female rats
1750 mg/kg bw: 3 female rats
5000 mg/kg bw: 1 female rat
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration.
During the follow-up period (two weeks), changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily.
Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death. Changes in weight were calculated if survival exceeds one day.
- Necropsy of survivors performed: yes, at the end of the experiments, all surviving animals were sacrificed and inspected macroscopically. Necropsy and macroscopic inspection of animals which died prematurely were carried out as soon as possible after exitus.
The LD50 value and the confidence interval were calculated using the software “AOT425statpgm (Version:1.0)”.
Dose descriptor:
Effect level:
1 030 mg/kg bw
Based on:
test mat.
95% CL:
550 - 1 750
175 mg/kg bw: no animal died prematurely.
550 mg/kg bw: no animal died prematurely.
1750 mg/kg bw: all animals died prematurely within 3 hours after administration
5000 mg/kg bw: animal died prematurely within 24 hours after administration
Clinical signs:
other: 175 mg/kg bw: no signs of toxicity 550 mg/kg bw: no signs of toxicity 1750 mg/kg bw: reduced motility, ataxia, reduced muscle tone, dyspnoea and dorsal or lateral position in all animals. Clinical signs occurred up to 60 minutes after administration. 5000
Gross pathology:
No pathological findings were noted at necropsy.
Interpretation of results:
Toxicity Category IV
Migrated information Criteria used for interpretation of results: EU
LD50 (female rats): 1030 mg/kg bw
According to the Directive 67/548/EEC and its subsequent amendments, the test substance is acutely toxic via the oral route (R22; Xn).
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is classified as acute toxic via the oral route (Category 4; H302).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
1 030 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity - Strontium neodecanoate

One reliable animal study according to OECD 425 is considered to be reliable without restrictions. The LD50 value was determined to be 1030 mg/kg bw. The test item is acutely toxic via the oral route.




Acute dermal toxicity

In the absence of measured data on dermal absorption, current guidance suggests the assignment of either 10 % or 100 % default dermal absorption rates. In contrast, the currently available scientific evidence on dermal absorption of metals yields substantially lower figures, which can be summarised briefly as follows:

Measured dermal absorption values for metals or metal compounds in studies corresponding to the most recent OECD test guidelines are typically 1 % or even less. Therefore, the use of a 10 % default absorption factor is not scientifically supported for metals. This is corroborated by conclusions from previous EU risk assessments (Ni, Cd, Zn) and current metal risk assessments under REACH, which have derived dermal absorption rates of 2 % or far less (but with considerable methodical deviations from existing OECD methods) from liquid media.

However, considering that under industrial circumstances many applications involve handling of dry powders, substances and materials, and since dissolution is a key prerequisite for any percutaneous absorption, a factor 10 lower default absorption factor may be assigned to such “dry” scenarios where handling of the product does not entail use of aqueous or other liquid media. This approach was taken in the in the EU RA on zinc. A reasoning for this is described in detail elsewhere (Cherrie and Robertson, 1995), based on the argument that dermal uptake is dependent on the concentration of the material on the skin surface rather than its mass. The following default dermal absorption factors for metal cations are therefore proposed (reflective of full-shift exposure, i.e. 8 hours): From exposure to liquid/wet media: 1.0 %; From dry (dust) exposure: 0.1 %. This approach is consistent with the methodology proposed in HERAG guidance for metals (HERAG fact sheet - assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds; EBRC Consulting GmbH / Hannover /Germany; August 2007).




Acute dermal toxicity

Neodecanoic acid has a low potential for toxicity via the dermal route. 

In a study that assessed acute dermal toxicity, male and female rats were exposed to 4 ml/kg (3640 mg/kg) neodecanoic acid via an occluded dermal patch for 24 hours. After 24 hours, the patch was removed and clinical observations were made once daily for 9 days. There were no deaths observed in this study and there were no signs of a toxicity response.  It is concluded that the LD50 is greater than 3640 mg/kg. 



Acute dermal toxicity

No acute dermal toxicity study is available, thus the acute dermal toxicity will be addressed with existing data on the dissociation products strontium and neodecanoate. Signs of acute dermal toxicity are not expected for strontium neodecanoate, since dermal absorption of the moiety strontium is low and the moiety neodecanoate have not shown signs of acute dermal toxicity in experimental testing (LD50 > 2000 mg/kg).

Under the assumption that the moieties of strontium neodecanoate show their toxicological profile individually upon dissolution, the acute dermal (systemic) toxicity of strontium neodecanoate can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section

A study for acute toxicity via inhalation was not conducted with strontium neodecanoate, since it is produced and placed on the market in a form in which no inhalation hazard is anticipated, thus acute toxic effects are not likely to occur during manufacture and handling of that substance. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.


The calculated dermal LD50 forstrontiumneodecanoate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute dermal toxicity.

Justification for classification or non-classification

Acute oral toxicity

The available guideline-conform study conducted under GLP was used for classification.According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is classified as acute toxic via the oral route (Category 4; H302).

Specific target organ toxicant (STOT) - single exposure: oral

The classification criteria according to Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value, oral for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification required.

Acute dermal toxicity

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, strontium neodecanoate does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity.