Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 oral toxicity: Weight of evidence. Experimental results from acute oral toxicity studies performed with the test substance and some analogues are available:

Diundecyl phthalate (DUP): No information on the method used. The acute oral LD50 value of the test substance is higher than 15.8 g/kg bw in rats.

Ditridecyl phthalate (DTP): Method in accordance with OECD Guideline 401, following GLP. Based on the read-across approach, the acute oral LD50 value of DUP is determined to be higher than 1788.6 mg/kg bw in rats.

Diisodecyl phthalate (DIDP): No information on the method used. Based on the read-across approach, the acute oral LD50 value of DUP is 68.02 g/kg bw in rats.

Diisodecyl phthalate (DIDP): Method of Thompson (Thompson W R, 1945) and tables of Weil (Weil C. S., 1952). Based on the read-across approach, the acute oral LD50 value of DUP is higher than 63.77 g/kg bw in rats.

In a weight of evidence approach the key study was selected to be the acute toxicity study performed with DUP for CSA since no toxicity was observed in any of the studies performed with different phthalates.

Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.

Acute dermal toxicity: Key study. Test method in accordance with OECD Test Guideline 402, following GLP. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The study predates GLP and the description of method is not provided.
Principles of method if other than guideline:
- Principle of test: Rats given single doses of DUP of up to at least 15.8 g/kg bw.
- Short description of test conditions: No data on test method.
- Parameters analysed / observed: Animals observed for signs of toxicity.
GLP compliance:
no
Test type:
other: No data
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
up to at least 15.8 g/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No significant toxic effects
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance is higher than 15.8 g/kg bw in rats.
Executive summary:

A single dose toxicity study was conducted with DUP in rats up to at least 15.8 g/kg bw. No mortalities were reported. Under the conditions of this study DUP was considered practically non-toxic. Thus, it can be concluded that the acute oral LD50 value of the test substance is higher than 15.8 g/kg bw in rats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
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 Japan
- Age at study initiation: 5-6 weeks old
- Weight at study initiation: 103.8 to 112.1 g (males) and 93.3 to 98.6 g (females)
- Fasting period before study: 18 hours
- Housing: animals were housed in a metallic wire mesh cage (220 W × 270 D × 190 H mm).
- Diet (e.g. ad libitum): Ad libitum. (CE-2, CLEA Japan).
- Water (e.g. ad libitum): Ad libitum. Tap water (Hadano city water supply station).
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 to 25.5°C
- Humidity (%): 51 to 64%
- Air changes (per hr): At least 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours contimuous light (07.00 to 19.00 h)


Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A preliminary test was conducted in male rats with doses of 20, 200 and 2000 mg/kg bw. No deaths were observed and no general effects other than diarrhoea were observed during the 8-days observation period. Based on these results a limit main test was planned with a single dose of 2000 mg/kg bw. In addition, as diarrhoea was attributed to corn oil used in the preliminary test, a solvent control only with corn oil was used in the main test.
Doses:
0 (solvent control) and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and general state during the administration day at 1h, 2 h, 3h, 4h, 6 h after adminitration (day 1 of observation) and then once daily from 2nd day to 15th day. Body weights were measured immediately before administration, and at observation days 2, 4, 8, 11 and 15.
- Necropsy of survivors performed: yes. At termination, macroscopic observations were performed on the following organs: brain, pituitary gland, thymus, heart, lung, liver, kidney, spleen, pancreas, reproductive organs, submandibular gland, thyroid gland, the adrenal glands, aorta, trachea, oesophagus, gastrointestinal tract, bladder, ocular (including Harder's gland), skin, mammary gland, cervical and mesenteric lymph nodes, femoral bone marrow and tongue.
- Other examinations performed:
At the time of autopsy, heart, lung, liver, kidney, spleen and stomach of male No. 6 were preserved in formalin for histopathologic examination in case macroscopic findings were observed.

Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: Diarrhoea was observed in the 2000 mg/ kg administration group, in 3 cases at 2 to 6 hours after administration for males and in 2 cases in females from 30 minutes to 2 hours after administration. However, diarrhoea was also observed in the solvent contro
Gross pathology:
The macroscopic examination of sacrificed rats did not reveal any abnormality.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance was found to be higher than 2000 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of ditridecyl phthalate was tested in accordance with OECD Guideline 401, following GLP. Based on the results of a preliminary assay conducted in male rats with doses of 20, 200 and 2000 mg/kg bw, a limit test with a single dose of 2000 mg/kg bw was performed with 5 females and 5 males rats with corn oil as vehicle. A solvent control group with corn oil only and the same number of animals was included as diarrhoea found in the preliminary test was attributed to corn oil. The body weight evolution of the animals remained normal during the study. No clinical signs were observed except for some cases of diarrhoea which was also present in the control group. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. Based on these results, it was estimated that the LD50 of ditridecyl phthalate in rats by single oral administration was higher than 2000 mg / kg in both males and females.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The study predates GLP and the description of method is not provided.
Principles of method if other than guideline:
- Principle of test: The study collects toxicity data relating to the phthalic acid esters used in food packaging. No data on test method.
GLP compliance:
no
Test type:
other: no data
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
No data
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
64 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance is 64 g/kg bw in rats
Executive summary:

The study collects toxicity data relating to the phthalic acid esters used in food packaging. All phthalates studied have a low order of acute toxicity. In summary, the available information indicates that the levels of phthalates occurring in the diet from authorized uses do not pose any toxicological hazard. It is recognized that this statement is based in part on the premise that phthalates as a class are metabolized in a similar manner, thus allowing a general approach to the toxicity of these compounds. The acute oral LD50 value of the test substance is 64 g/kg bw in rats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The study predates GLP and limited details provided.
Principles of method if other than guideline:
- Principle of test: Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson (Thompson W R, 1945) using the Tables of Weil (Weil C. S., 1952).
GLP compliance:
no
Test type:
other: no data
Limit test:
no
Species:
rat
Strain:
Wistar
Remarks:
(Carworth-Wistar)
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 wks of age
- Weight at study initiation: 90 to 120 g
- Fasting period before study: Non-fasted
- Diet (e.g. ad libitum): Rockland rat diet, complete
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 64 mL/kg
Doses:
Dosages were arranged in a logarithmic series differing by a factor of two up to 64 mL/kg bw.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
The LD50 value and its fiducial range were estimated by the method of Thompson (Thompson W R, 1945) using the Tables of Weil (Weil C. S., 1952).
Fort he test substance, as no dosage resulted in fractional mortality, the fiducial range was not calculated.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 64 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to ca. 60 g/kg bw
Mortality:
No mortality occurred during the study.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance is higher than 64 mL/kg bw in rats which is equivalent to ca. 60 g/kg bw.

Executive summary:

Single oral dose toxicity was estimated following the method of Thompson (Thompson W R, 1945) and tables of Weil (Weil C. S., 1952) by the gastric intubation of groups of five non-fasted Carworth-Wistar male rats. The test substance was administered undiluted with maximum dose of 64 mL/kg bw. Animals were observed during a 14-day period. No mortality occurred during the study, thus the LD50 was determined to be higher than 64 mL/kg bw which is equivalent to ca. 60 g/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Both the target substance (DUP) and the source substance (DTP) belong to the OECD HPV category High Molecular Weight Phthalate Ester (HMWPE) which consists of esters with an alkyl carbon backbone with 7 carbon (C) atoms or greater. Thus, these substances share the same functional groups and also have comparable environmental and toxicological properties.
See attached the reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 788.6 mg/kg bw
Based on:
other: Read-across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50> 2000 mg/kg bw
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue DTP, the acute oral LD50 value of DUP is determined to be higher than 1788.6 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of ditridecyl phthalate was tested in accordance with OECD Guideline 401, following GLP. Based on the results of a preliminary assay conducted in male rats with doses of 20, 200 and 2000 mg/kg bw, a limit test with a single dose of 2000 mg/kg bw was performed with 5 females and 5 males rats with corn oil as vehicle. A solvent control group with corn oil only and the same number of animals was included as diarrhoea found in the preliminary test was attributed to corn oil. The body weight evolution of the animals remained normal during the study. No clinical signs were observed except for some cases of diarrhoea which was also present in the control group. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. Thus, it was estimated that the LD50 of ditridecyl phthalate in rats by single oral administration was higher than 2000 mg / kg in both males and females. Based on these results, the read-across approach was applied and the LD50 of diundecyl phthalate in rats by single oral administration was calculated to be higher than 1788.6 mg / kg in both males and females.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The target substance (DUP) belongs to the OECD HPV category High Molecular Weight Phthalate Ester (HMWPE) which consists of esters with an alkyl carbon backbone with 7 carbon (C) atoms or greater. The source substance (DIDP) although is not formally part of this category as it was assessed previously, it satisfies the category definition as its backbone length is C7 or above and also produces similar effects of developmental or reproductive toxicity. Thus, these substances share the same functional groups and also have comparable environmental and toxicological properties.
See attached the reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
68 020.6 mg/kg bw
Based on:
other: Read across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50 = 64000 mg/kg bw
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue DIDP, the acute oral LD50 value of DUP is 68.02 g/kg bw in rats.

Executive summary:

The study collects toxicity data relating to the phthalic acid esters used in food packaging. All phthalates studied have a low order of acute toxicity. In summary, the available information indicates that the levels of phthalates occurring in the diet from authorized uses do not pose any toxicological hazard. It is recognized that this statement is based in part on the premise that phthalates as a class are metabolized in a similar manner, thus allowing a general approach to the toxicity of these compounds. The acute oral LD50 value of diisodecyl phthalate (DIDP) is 64 g/kg bw in rats. Based on these results, the read-across approach was applied and the acute oral LD50 of diundecyl phthalate (DUP) is 68.02 g/kg bw in rats.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The target substance (DUP) belongs to the OECD HPV category High Molecular Weight Phthalate Ester (HMWPE) which consists of esters with an alkyl carbon backbone with 7 carbon (C) atoms or greater. The source substance (DIDP) although is not formally part of this category as it was assessed previously, it satisfies the category definition as its backbone length is C7 or above and also produces similar effects of developmental or reproductive toxicity. Thus, these substances share the same functional groups and also have comparable environmental and toxicological properties.
See attached the reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 63 769 mg/kg bw
Based on:
other: Read across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50 > 60000 mg/kg bw
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue DIDP, the acute oral LD50 value of DUP is higher than 63.77 g/kg bw in rats.

Executive summary:

Single oral dose toxicity was estimated following the method of Thompson (Thompson W R, 1945) and tables of Weil (Weil C. S., 1952) by the gastric intubation of groups of five non-fasted Carworth-Wistar male rats. Diisodecyl phthalate (DIDP) was administered undiluted with maximum dose of 64 mL/kg bw. Animals were observed during a 14-day period. No mortality occurred during the study, thus the LD50 of DIDP was determined to be higher than 64 mL/kg bw which is equivalent to ca. 60 g/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 of diundecyl phthalate (DUP) is calculated to be higher than 63.77 g/kg bw in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 800 mg/kg bw
Quality of whole database:
A weight of evidence approach has been applied. Several experimental studies are available with a Klimisch score of 2 or 4.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.
Clinical signs:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 August 2018 - 23 August 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Remarks:
(SPF Caw)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle – France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 220.3 g (SD = 4 g)
- Fasting period before study: not specified.
- Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put together into their cage. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free wood shavings which were changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): Ad libitum. Teklad Global 16% Protein Rodent Diet (ENVIGO 2016).
- Water (e.g. ad libitum): Ad libitum. Drinking water (tap-water from public distribution system). Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas – Eurofins (FRANCE).
- Acclimation period: the animals were acclimatized for at least 5 days before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC to 25ºC
- Humidity (%): 30 to 70%
- Air changes (per hr): >10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light (07.00 to 19.00) and 12 hours dark cycle.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: at least 10% of the body surface area.
- Type of wrap if used: porous gauze dressing (50 mm x 50 mm non-woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic microporeTM adhesive tape from 3M).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.13 mL/kg body weight
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A
Duration of exposure:
24 h
Doses:
Range finding study: 2000 mg/kg body weight
Main study: 2000 mg/kg body weight
No. of animals per sex per dose:
Range finding study: 1 female per dose
Main study: 2 females per dose
Control animals:
yes
Remarks:
(study performed on three females receiving distilled water by topical application under requirements of OECD Guideline 402)
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At each step, the animals were observed three times on test day 0 (day of administration), i.e. at T0+30 min, T0+3h and T0+5h, and once daily during days 1 to 14 post administration. The body weights were recorded on test day 0 (just before administration) then on D2, D7, and D14.
- Necropsy of survivors performed: yes. At termination, gross pathological findings were recorded and reported.
- Other examinations performed:
Clinical observations: spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex and treatment site (erythema, dryness of the skin, scab, etc.)
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No systemic clinical sign related to the administration of the test item was observed.
Gross pathology:
The macroscopic examination of the animal at the end of the study did not reveal treatment-related changes.

Table 1: Body weight and weight gain in grams

FEMALES

D0

D2

D2-D0

D7

D7-D0

D14

D14-D0

Rf2808

216

222

6

240

24

261

45

Rf2817

224

229

5

245

21

267

43

Rf2818

221

226

5

240

19

264

43

MEAN

220.3

225.7

5.3

241.7

21.3

264.0

43.7

SD

4.0

3.5

0.6

2.9

2.5

3.0

1.2
Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats.

Executive summary:

The acute dermal toxicity of the test item was studied according to OECD Guideline 402 (GLP study). 3 female Sprague-Dawley rats were tested for a exposure period of 24 h. Initially, a range finding study was conducted at a single dose of 2000 mg/kg bw in one animal. Based on the results of this preliminary, two additional rats were tested at a dose of 2000 mg/kg bw. No mortality was observed. The body weight evolution of the animals remained normal during the study. No systemic clinical sign related to the administration of the test item was observed. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. Based on these results, the test item was determined to be non toxic, with an LD50 > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Key study with Klimisch score = 1

Additional information

Acute oral toxicity: Weight of evidence from experimental results with the test substance or some analogues:

DUP: A single dose toxicity study was conducted with DUP in rats up to at least 15.8 g/kg bw. No mortalities were reported. Under the conditions of this study DUP was considered practically non-toxic. Thus, it can be concluded that the acute oral LD50 value of the test substance is higher than 15.8 g/kg bw in rats.

DTP: The acute oral toxicity of ditridecyl phthalate was tested in accordance with OECD Guideline 401, following GLP. Based on the results of a preliminary assay conducted in male rats with doses of 20, 200 and 2000 mg/kg bw, a limit test with a single dose of 2000 mg/kg bw was performed with 5 females and 5 males rats with corn oil as vehicle. It was estimated that the LD50 of ditridecyl phthalate in rats by single oral administration was higher than 2000 mg / kg in both males and females. Based on these results, the read-across approach was applied and the LD50 of diundecyl phthalate in rats by single oral administration was calculated to be higher than 1788.6 mg / kg in both males and females.

DIDP: The study collects toxicity data relating to the phthalic acid esters used in food packaging. All phthalates studied have a low order of acute toxicity. In summary, the available information indicates that the levels of phthalates occurring in the diet from authorized uses do not pose any toxicological hazard. It is recognized that this statement is based in part on the premise that phthalates as a class are metabolized in a similar manner, thus allowing a general approach to the toxicity of these compounds. The acute oral LD50 value of diisodecyl phthalate (DIDP) is 64 g/kg bw in rats. Based on these results, the read-across approach was applied and the acute oral LD50 of DUP is 68.02 g/kg bw in rats.

DIDP: Single oral dose toxicity was estimated following the method of Thompson (Thompson W R, 1945) and tables of Weil (Weil C. S., 1952) by the gastric intubation of groups of five non-fasted Carworth-Wistar male rats. DIDP was administered undiluted with maximum dose of 64 mL/kg bw. Animals were observed during a 14-day period. No mortality occurred during the study, thus the LD50 of DIDP was determined to be higher than 64 mL/kg bw which is equivalent to ca. 60 g/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 of diundecyl phthalate (DUP) is calculated to be higher than 63.77 g/kg bw in rats.

Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.

Acute dermal toxicity: Key study. The acute dermal toxicity of the test item was studied according to OECD Guideline 402 (GLP study). 3 female Sprague-Dawley rats were tested for a exposure period of 24 h. Initially, a range finding study was conducted at a single dose of 2000 mg/kg bw in one animal. Based on the results of this preliminary, two additional rats were tested at a dose of 2000 mg/kg bw. No mortality was observed. The body weight evolution of the animals remained normal during the study.No systemic clinical sign related to the administration of the test item was observed. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects.Based on these results, the test item was determined to be non toxic, with an LD50 > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.