Registration Dossier

Administrative data

Description of key information

LD50 oral, rat > 2000 mg/kg bw by analogy with both Cerium and iron oxide isostearates (Active matter of DPX10 and Active matter of DPX11)

LD50 dermal, rat > 2000 mg/kg bw by analogy with Cerium and iron oxide isostearate (Active matter of DPX10)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 2001 to 21 Dec 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
room temperature sometimes out of the target (minor deviation)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, L'Arbresle, France.
- Age at study initiation: on the day of treatment, the animals were approximately 6 weeks old.
- Weight at study initiation: 178 ± 6 g for the males and 132 ± 12 g for the females (on the day of treatment)
- Fasting period before study: approximately 18 hours
- Housing: in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm), 1 to 7 animals/sex during the acclimation period and 3 rats/sex/group during the treatment period
- Diet: free access to A04 C pelleted diet
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron), provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour
- Photoperiod: 12 h light/12 h dark

IN-LIFE DATES: From 18 July 2001 (first treatment) to 8 August 2001 (necropsy of the last animal)
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: data not available
- Lot/batch no.: 70K0127
- Purity: data not available

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION: The test substance was mixed with the required quantity of vehicle, using an ultra-turrax (freshly on the morning of administration).

CLASS METHOD
- Rationale for the selection of the starting dose: the information on the toxic potential of the test substance suggested that mortality was unlikely at the highest dose-level (2000 mg/kg bw).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical signs and mortality: frequently during the hours following administration of the test substance, and at least once a day thereafter.
> Body weight: just before administration of the test substance on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No signs of toxicity were observed at this dose-level
Mortality:
No deaths were observed at 2000 mg/kg bw during the study.
Clinical signs:
No clinical signs were observed at 2000 mg/kg bw during the study.
Body weight:
The body weight gain of the treated animals was similar to that of the historical control animals.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of the test substance is > 2000 mg/kg bw (with no signs of toxicity at the dose level).
Executive summary:

In an acute oral toxicity study according to OECD TG 423 and GLP (CIT report 22316 TAR), scored as validity 1 according to Klimisch criteria, groups of fasted 6-week old Sprague-Dawley rats (3/sex) were given a single oral dose of cerium and iron oxide isostearate in corn oil at the dose of 2000 mg/kg bw (limit test) and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15.

 

Under the experimental conditions, the oral LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats.

No effects were observed during the observation period (no clinical signs no mortality and no effect on body weight) and at necropsy.

 

No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 21 June to 22 October 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-saint-Isle, France
- Age at study initiation: on the day of treatment, the animals were approximately 8 weeks old.
- Weight at study initiation: 202 ± 9 g (on the day of treatment)
- Fasting period before study: approximately 18 hours
- Housing: in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm), 1 to 7 animals/sex during the acclimation period and 3 rats/sex/group during the treatment period
- Diet: free access to adapted pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron), provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour
- Photoperiod: 12 h light/12 h dark

IN-LIFE DATES: From 29 June 2004 (first treatment) to 15 July 2004 (necropsy of the last animal)
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle: 2 x 10 mL/kg
- Justification for choice of vehicle: data not available
- Lot/batch no.: 122K0131

MAXIMUM DOSE VOLUME APPLIED: 2 x 10 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: as the information on the toxic potential of the test item suggested that mortality was unlikely at the highest dose-level, the starting dose-level of 2000 mg/kg was chosen.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 x 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical signs and mortality: frequently during the hours following administration of the test substance, and at least once a day thereafter.
> Body weight: just before administration of the test substance on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality and no systemic toxicity were observed.
Mortality:
No mortality occurred during the study.
Clinical signs:
Only hypoactivity, piloerection and dyspnea were observed on day 1 in all animals of the first treated group. No clinical signs were noted in the second treated group.
Body weight:
The body weight gain of 2/3 females of the second treated group was slightly reduced during the first or second week of the study when compared to lab historical control animals. The overall body weight of the other animals was not affected by treatment with the test item.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of the test substance is > 2000 mg/kg bw (with no mortality at the dose level).
Executive summary:

In an acute oral toxicity study according to OECD TG 423 and GLP (CIT report 28266 TAR), scored as validity 1 according to Klimisch criteria, groups of fasted 8-week old Sprague-Dawley rats (2 x 3 females) were given a single oral dose of cerium and iron oxide isostearate (active matter of DPX11) in corn oil at the dose of 2000 mg/kg bw (limit test) and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15.

 

Under the experimental conditions, the oral LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats.

No mortality occurred during the study.

Only hypoactivity, piloerection and dyspnea were observed on day 1 in all animals of the first treated group. No clinical signs were noted in the second treated group.

The overall body weight of the other animals was not affected by treatment with the test item and no abnormalities were seen at the necropsy.

No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Data from cerium and iron oxide isosterate (Ce:Fe ratio 0.5:0.5), a substance that presents structural similarities with iron oxide isostearate was used to cover this endpoint. See the Read-across justification document (Justification for analogue approach) attached in IUCLID Section 13.2 for the justification of the read-across.
See also the original letters from the French Competent Authorities requiring the read across to be done with Cerium and iron oxide isostearate substances, attached in Section 13.2 as well (French CA testing program July 2005, and French CA testing program Sep 2007).
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of cerium and iron oxide isosterate (active matter of DPX10), an analogue of iron oxide isostearate, was found to be > 2000 mg/kg bw. Based on the stuctural similarities between traget and sources substances, the same LD50 value (> 2000 mg/kg bw) is assumed for iron oxide isostearate.
Executive summary:

In an acute oral toxicity study according to OECD TG 423 and GLP (CIT report 22316 TAR), scored as validity 1 according to Klimisch criteria, groups of fasted 6-week old Sprague-Dawley rats (3/sex) were given a single oral dose of cerium and iron oxide isostearate (Active matter of DPX 10), a structural analogue of iron oxide isostearate, in corn oil at the dose of 2000 mg/kg bw (limit test) and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15.

No effects were observed during the observation period (no clinical signs no mortality and no effect on body weight) and at necropsy. Therefore, the oral LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats.

Due to the structural similarities between cerium and iron oxide isostearate (Active matter of DPX10) and iron oxide isostearate, same results are assumed for iron oxide isostearate.

 

No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Data from cerium and iron oxide isostearate (Ce:Fe ratio 0.1:0.9), a substance that presents structural similarities with iron oxide isostearate was used to cover this endpoint. See the Read-across justification document (Justification for analogue approach) attached in IUCLID Section 13.2 for the justification of the read-across.
See also the original letters from the French Competent Authorities requiring the read across to be done with Cerium and iron oxide isostearate substances, attached in Section 13.2 as well (French CA testing program July 2005, and French CA testing program Sep 2007).

Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of cerium and iron oxide isosterate, an analogue of iron oxide isostearate, was found to be > 2000 mg/kg bw. Based on the stuctural similarities between traget and sources substances, the same LD50 value (> 2000 mg/kg bw) is assumed for iron oxide isostearate.
Executive summary:

In an acute oral toxicity study according to OECD TG 423 and GLP (CIT report 28266 TAR), scored as validity 1 according to Klimisch criteria, groups of fasted 8-week old Sprague-Dawley rats (2 x 3 females) were given a single oral dose of cerium and iron oxide isostearate (active matter of DPX11), a structural analogue of iron oxide isostearate, in corn oil at the dose of 2000 mg/kg bw (limit test) and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15.

No mortality occurred during the study. Only hypoactivity, piloerection and dyspnea were observed on day 1 in all animals of the first treated group. No clinical signs were noted in the second treated group. The overall body weight of the other animals was not affected by treatment with the test item and no abnormalities were seen at the necropsy.

Under the experimental conditions of this study, the oral LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats.

Due to the structural similarities between cerium and iron oxide isostearate (Active matter of DPX11) and iron oxide isostearate, same results are assumed for iron oxide isostearate.

No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
OECD guideline and GLP study, meets REACH and CLP requirements

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from Aug. 2001 to 12 Dec. 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
relative humidity sometimes out of the target (minor deviation)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, L'Arbresle, France.
- Age at study initiation: on the day of treatment, the animals were approximately 8 weeks old.
- Weight at study initiation: 261 ± 11 g for the males and 225 ± 9 g for the females (on the day of treatment).
- Fasting period before study: no
- Housing:
> during acclimation period: 1 to 7 animals/sex in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm).
> during the treatment period: individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm).
- Diet: free access to A04 C pelleted diet.
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum.
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 30 to 70% (with minor deviation)
- Air changes: approximately 12 cycles/hour
- Photoperiod: 12 h light/12 h dark

IN-LIFE DATES: From 19 September 2001 (first treatment) to 3 October 2001 (necropsy of the last animal)
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area.
- % coverage: approximately 10% of the total body surface.
- Type of wrap if used: gauze pad held by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: yes (with a moistened gauze pad)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Concentration: undiluted
- For solids, paste formed: yes (applied on a hydrophilic gauze pad pre-moistened with 2 mL of water)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
five males and five females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical signs and mortality: frequently during the hours following administration of the test substance, and thereafter at least once a day until day 15.
> body weight: just before administration of the test substance on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: any local cutaneous reaction was recorded from day 2.
Statistics:
Not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No deaths occurred during the observation period.
Clinical signs:
No clinical signs and no cutaneous reactions were observed during the observation period.
Body weight:
A reduced body weight gain or a slight body weight loss was seen in 3/5 females between day 1 and day 8, without any relevant consequence at the end of the observation period. The overall body weight gain of the other animals was similar to that of the lab's historical control animals.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Interpretation of results:
GHS criteria not met
Conclusions:
Dermal LD50 of the test compound is higher than 2000 mg/kg bw for male and female rats.
Executive summary:

In an acute dermal toxicity study according to OECD TG 402 and GLP (CIT report No. 22319 TAR), scored as validity 1 according to Klimisch criteria, a group of 8-week old Sprague-Dawley rats (5/sex) were applied a single dermal dose of undiluted cerium and iron oxide isostearate at the dose of 2000 mg/kg bw (limit test) under a semi-occlusive dressing applied for 24 hours, and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15. Local tolerance was also observed from Day 2.

Under the experimental conditions, the dermal LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats.

No mortality occurred during the observation period. No clinical signs or local effects were reported.

A reduced body weight gain or a slight body weight loss was seen in 3/5 females between day 1 and day 8, without any relevant consequence at the end of the observation period. The overall body weight gain of the other animals was similar to that of the lab's historical control animals. No relevant findings were seen at necropsy on day 14.

 

No classification for acute dermal toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Data from cerium and iron oxide isosterate, a substance that presents structural similarities with iron oxide isostearate, was used to cover this endpoint. See the Read-across justification document (Justification for analogue approach) attached in IUCLID Section 13.2 for the justification of the read-across.
See also the original letters from the French Competent Authorities requiring the read across to be done with Cerium and iron oxide isostearate substances, attached in Section 13.2 as well (French CA testing program July 2005, and French CA testing program Sep 2007).
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 of cerium and iron oxide isosterate, an analogue of iron oxide isostearate, was found to be > 2000 mg/kg bw. Based on the stuctural similarities between traget and sources substances, the same dermal LD50 value (> 2000 mg/kg bw) is assumed for iron oxide isostearate.
Executive summary:

In an acute dermal toxicity study performed according to OECD TG 402 (CIT report No.22319TAR, 2001), a group of Sprague-Dawley rats (5/sex) were treated with a single dermal dose of undiluted cerium and iron oxide isostearate, a structural analogue of iron oxide isostearate, at the dose of 2000 mg/kg bw (limit test) under a semi-occlusive dressing for 24 hours. The animals were observed during 14 days. Clinical signs and mortality were checked frequently during the study. Body weight was measured on days 1, 8 and 15. Local tolerance was also observed from Day 2 and necropsy was performed at the end of the study.

No mortality occurred during the observation period. No clinical signs or local effects were reported. The overall body weight gain of the animals was similar to that of the lab's historical control animals. No relevant findings were seen at necropsy at the end of the study.

Under the experimental conditions, the dermal LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats therefore warranting no classification.

Due to the structural similarities between cerium and iron oxide isostearate and iron oxide isostearate, same results are assumed for iron oxide isostearate.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
OECD guideline and GLP study, meets REACH and CLP requirements

Additional information

There is no data available on the test item but the acute toxicity of iron oxide isostearate was assessed by analogy with both cerium and iron oxide isostearates (Active Matter of DPX10 and Active matter of DPX11) in accordance with the testing program established by the Competent Authorities in July 2005 (see document " 050721-AC-Programme études-DPX13.pdf" attached in section 13.2 and the Read-across justification document attached in this section as well.).

Active matter of DPX10 was tested in rats using the two following routes of administration: oral and dermal while Active matter of DPX11 was tested for the acute toxicity using oral route only. Each of these key studies should be quoted as reliability 1 according to Klimisch criteria since the studies were performed according to OECD guidelines and in accordance with GLP.

 

Acute toxicity : oral

In an acute oral toxicity study performed according to OECD TG 423 (CIT report 28266 TAR, 2001), groups of Sprague-Dawley rats (3/sex) were given a single oral dose of cerium and iron oxide isostearate (Active matter of DPX10, CAS 753480-32-9) in corn oil at the dose of 2000 mg/kg bw (limit test) and were observed for 14 days. Clinical signs and mortality were checked frequently during the study period. Body weight was measured on days 1, 8 and 15. Necropsy was performed at the end of the study.

No effects were observed during the observation period (no clinical signs no mortality and no effect on body weight) and at necropsy. The LD50 value of cerium and iron oxide isostearate (Active matter of DPX10) determined in this study was higher than 2000 mg/kg bw, therefore warranting no classification according to EU criteria.

In an acute oral toxicity study performed according to OECD TG 423 and GLP (CIT report 28266 TAR, 2004), groups of fasted 8-week old Sprague-Dawley rats (2 x 3 females) were given a single oral dose of cerium and iron oxide isostearate (active matter of DPX11) in corn oil at the dose of 2000 mg/kg bw (limit test) and were observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15. All animals were subjected to necropsy.

No mortality occurred during the study. Only hypoactivity, piloerection and dyspnea were observed on day 1 in all animals of the first treated group. No clinical signs were noted in the second treated group. The overall body weight of the other animals was not affected by treatment with the test item. No apparent abnormalities were observed at necrpsy.

Under the experimental conditions, the oral LD50 of the test substance cerium and iron oxide isostearate (Active matter of DPX11) is higher than 2000 mg/kg in rats. No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

Thus, based on the absence of acute toxicity by oral route with both analogues, the same is assumed for iron oxide isostearate and therefore no classification is also warranted for this substance .

Acute toxicity : dermal

In an acute dermal toxicity study performed according to OECD TG 402 (CIT report No. 22319 TAR, 2001), a group of Sprague-Dawley rats (5/sex) were treated with a single dermal dose of undiluted cerium and iron oxide isostearate (active matter of DPX10, CAS 753480-32-9) at the dose of 2000 mg/kg bw (limit test) under a semi-occlusive dressing for 24 hours. The animals were observed during 14 days. Clinical signs and mortality were checked frequently during the study. Body weight was measured on days 1, 8 and 15. Local tolerance was also observed from Day 2 and necropsy was performed at the end of the study.

No mortality occurred during the observation period. No clinical signs or local effects were reported. The overall body weight gain of the animals was similar to that of the lab's historical control animals. No relevant findings were seen at necropsy at the end of the study.

Under the experimental conditions, the dermal LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats therefore warranting no classification. And the same is assumed for iron oxide isostearate.

 Acute toxicity : inhalation

Acute inhalation study was not done since the substance is produced and commercialized as a suspension in a solvant. In addition, the substance is produced and used in closed systems.  Thus, the handling of the registered substance does not produce vapour, aerosols or droplets and exposure of humans is unlikely during the whole life cycle. Furthermore, for the registration, the substance was extracted from its solvent for the testing. The extracted substance formed a melting/sticky powder that has prevented the testing via inhalation route.

Justification for classification or non-classification

Based on data on the analogous substances Cerium and iron oxide isostearates (Active matter of DPX10 and Active matter of DPX 11) which induced no mortality in the rat following a single exposure by oral and dermal route up to a limit dose/concentration of 2000 mg/kg bw, Iron oxide isostearate should not be classified for acute toxicity via the oral and dermal route as defined by the UN/EU GHS classification criteria.

Acute exposure does not induce any systemic effect and thus Iron oxide isostearate should also not be classified as STOT RE according to UN/EU GHS classficiation criteria.