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Diss Factsheets

Administrative data

Description of key information

The read across for substance, CAS: 118685 -22-6; EC: 453-490-7; is based upon the analogous substances to which basic form, degree of substitution  of functional groups is not considered to effect the proposed read across for the endpoint of acute toxicity via the oral, dermal or inhalatory route. Based on the information available for the read across substances, the substance is not expected to cause acute toxicity via the oral, dermal or inhalatory route.

All available acute oral toxicity studies category resulted in an acute oral LD50 > 2000 mg/kg bw.

All available acute dermal toxicity studies resulted in acute dermal LD50 > 2000 mg/kg bw.

All available acute inhalation toxicity studies resulted in acute inhalation LC50 > 5.0 mg/L.

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:
supporting study
Study period:
28 Mar - 4 Nov 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no analytical purity; method shortly described)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no analytical purity; method shortly described
GLP compliance:
no
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: Taconic Farms
- Fasting period before study: overnight
- Housing: individually in single wire bottom stainless steel suspended cages
- Diet: Purina Dawley Chow # 5002
- Water: Automatic watering; ad libitum
Route of administration:
oral: gavage
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 15 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity related to the administration of the test substance were observed up to the end of the 14-day observation period. However, all animals exhibited clear, oily perineal staining on the 1st, 2nd, and 3rd day following treatment; this condition normally regarded as an adverse effect, was considered to be a consequence of the high dose level administered and not considered a toxic sign.
Interpretation of results:
not classified
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
7 Dec - 23 Dec 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no analytical purity reported)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
no analytical purity reported
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
other: Albino Rats (Outbred). Stock: Sprague-Dawley-derived (CD) [Crl: CD (SD) IGS BR]
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kingston, New York, USA
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 279-318 g (males), 204-219 g (females)
- Fasting period before study: animals were fasted overnight prior administration
- Housing: 2 to 6 animals of the same sex per cage (during acclimation) und individual (during study) per cages. Cages were suspended, stainless cages with wire mesh bottoms.
- Diet: certified Rodent Diet, No. 5002 (PMI Nutrition International, Inc., St. Louis, MO), ad libitum
- Water: automatic watering system, Municipal water supply (Elizabethtown Water Company), ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 26
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were checked for viability daily. Each animal was examined (general condition, skin and fur, eyes nose, oral cavity, abdomen and external genitalia as well as evaluations of respiration and palpation for tissue masses) approximately 1, 2, and 4 hours after dosing and daily thereafter for 14 days. Individual body weights were determined on day 0 (at the time of fasting), day 1 (just prior to dosing; weights were used for calculation of doses), day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption, macroscopic post-mortem examination.
Key result
Sex:
male/female
Dose descriptor:
LD100
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity related to the administration of the test substance were observed up to the end of the 14-day observation period. However alopecia extremities on snout was seen in a single animal on day 9 through day 15 after the dose administration. This finding was not considered to be related to the administration of the test substance.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy revealed no substance-related findings.
Interpretation of results:
not classified
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (Only 2 male and 2 female rats were used, details on test substance not documented).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: Only two male and two female animals used
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Alderley Park SPF albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 215 g - 237 g; females: 145 g - 163 g
- Fasting period before study: 24 h
Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Duration of observation period following administration: not stated
- Other examinations performed: body weight, macroscopic abnormalities (post mortem)
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 period.
Clinical signs:
No significant signs of toxicity in females but males showed slight toxicity following a 2000 mg/kg bw dose.
Body weight:
Initial loss of weight (due to predose fasting) with normal weight gain after dosing.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.
Interpretation of results:
not classified
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
August 30th, 1983 - September 13th, 1983
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient for assessment due to reduced animal number. Only 2 male and 2 female animals were used, details on test substance not documented.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: Only two male and two female animals used, details on test substance not documented
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: >6 weeks
- Weight at study initiation: males: 282.5 g; females: 166.0 g
- Fasting period before study: 15 h
- Housing: Makrolon Type III cages
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: > 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 1.62 ml - 2.95 ml depending on body weight

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Frequency of observations and weighing: evaluation of mortality: twice daily; weighting on days 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Duration of observation period following administration: 14 d
- Other examinations performed: body weight, macroscopic abnormalities (post mortem)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
No significant signs of toxicity except for transient rough fur and reduced activity direct after dosing
Body weight:
Normal weight gain after dosing.
Gross pathology:
No macroscopic findings

The limit dose of 2000 mg/kg showed no mortality in male and female rats. Although only 2 animals per sex were tested, the observations do not indicate a toxic effect.

Interpretation of results:
not classified
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
3 substances available for read-across
Adequacy of study:
weight of evidence
Justification for type of information:
see attached justification in Section 13 for the full details
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: CAS 85116-93-4
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CAS 68424-31-7
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CAS 67762-53-2 (1984)
Key result
Sex:
male/female
Dose descriptor:
LD100
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CAS 67762-53-2 (1999)
Interpretation of results:
not classified
Conclusions:
The read across for substance, CAS: 118685-22-6; EC: 453-490-7; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute toxicity via the oral route. Based on the information available for the read across substances, the substance is not expected to cause acute toxicity via the oral route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
K2-4

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Mar - 05 Apr 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (only few data on test item and animal husbandry were given)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
(No details on test material and limited data on animal husbandry)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Alpk:APfSD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Alderly Park, Cheshire, UK
- Age at study initiation: approx. 7 weeks
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: dried and filtered air
- System of generating aerosols: glass concentric jet atomiser
- Method of particle size determination: Marple Cascade Impactor
- Temperature, humidity, pressure in air chamber: 20 L/min

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.51 µm/2.51
Analytical verification of test atmosphere concentrations:
yes
Remarks:
particulate concentrations of the test atmospheres close to the animals breathing zone were measured gravimetrically
Duration of exposure:
4 h
Concentrations:
5.0 mg/L (nominal)
5.10 mg/L (analytical)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for gross clinical abnormalities during exposure and were checked daily thereafter. A detailed examination was conducted after exposure on day 1 and on consecutive days, up to and including day 15. Individual body weights were recorded on Day 1 and Days 2, 3, 8 and day 15.
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.1 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.
Interpretation of results:
not classified
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
1 substance available for read across
Adequacy of study:
weight of evidence
Justification for type of information:
See the attached justification in section 13 for full details
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.1 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: CAS 68424-31-7
Interpretation of results:
not classified
Conclusions:
The read across for substance, CAS: 118685-22-6; EC: 453-490-7; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute toxicty via the inhalatory route. Based on the information available for the read across substances, the substance is not expected to be acutely toxic via the inhalatory route
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5 mg/m³
Quality of whole database:
K2

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
1 substance available for read across
Adequacy of study:
weight of evidence
Justification for type of information:
see the attached justification in section 13 for full details
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.
Remarks on result:
other: CAS 71010-76-9
Interpretation of results:
GHS criteria not met
Conclusions:
The substance, CAS 118685-22-6 ; EC 453-490-7, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute dermal toxicity. Based on the available information to read across to, the substance is not expected to be acutely toxic via the dermal route.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with acceptable restrictions. (Lack of data on test material.)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
(no data on test substance purity)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted in1992
Deviations:
yes
Remarks:
(no data on test substance purity)
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1998
Deviations:
yes
Remarks:
(no data on test substance purity)
GLP compliance:
yes
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: Harlan
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 247 - 253 g (males), 217 - 239 g (females)
- Housing: animals were group housed by sex upon receipt and individually housed upon assignment to study in compliance with the National Research Council " Guide for the Care and Use of Laboratory Animals".
- Diet: Harlan Teklad Rodent Diet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 23 - 59
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 9 Jan 2006
To: 23 Jan 2006
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin of the dorsal area of the trunk
- Type of wrap if used: the treated skin site was covered with a gauze patch/dental dam, wrapped with an elastic bandage and secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with water
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
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: Clinical observations were recorded immediately after dosing and at approximately 1, 2.5 and 4 h after dosing and daily thereafter through Day 15. Animals were weighed prior to dosing on Day 1 and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality/morbidity (twice daily)
Statistics:
Body weights were summarized using descriptive statistics (mean and standard deviation).
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 period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
Body weight gains of all animals were withinthe normal ranges during the whole study period.
Gross pathology:
Necropsy revealed no substance-related findings.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
EU: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
K2

Additional information

Acute Oral Toxicity

CAS 85116-93-4

An acute oral toxicity study (limit test) was conducted withFatty acids, C16-18 (even numbered), esters with pentaerythritol(CAS 85116-93-4) comparable to OECD Guideline 401 (Potokar, 1983). Reporting of test conditions and results was limited. The test substance was administered by gavage at a concentration of 2000 mg/kg bw to 2 male and female Wistar rats each. The animals were observed for 14 days following administration. No mortalities occurred during the study period. No significant signs of toxicity except for transient rough fur and reduced activity direct after dosing were observed. Normal weight gain was observed after dosing. Finally no macroscopic findings were found at necropsy. The acute oral LD50 was found to be greater than 2000 mg/kg bw.

CAS 67762-53-2

The acute toxicity via the oral route of Fatty acids, C5-9 tetraesters with pentaerythritol has been investigated in two studies with rats (CAS No. 67762-53-2).

An acute oral toxicity study (limit test) was performed according to OECD Guideline 420 (fixed dose procedure) (Zolyniene, 1999). Groups of 5 males and females fasted CD Sprague-Dawley rats received single oral gavage doses of 2000 mg/kg bw. The animals were observed for 14 days following administration. No mortalities occurred. One animal showed alopecia extremities on snout which was not considered treatment related. No further clinical signs of toxicity were reported. No effect on body weight was noted. Finally necropsy revealed no substance-related findings. Thus, the acute oral LD50 was found to be greater than 2000 mg/kg bw.

Another acute oral toxicity study (limit test) was performed comparable to OECD Guideline 401 (D’Aleo, 1984). The test substance was administered by gavage at a concentration of 15000 mg/kg bw to groups of 5 male and female Sprague-Dawley rats. The animals were observed for 14 days following administration. No mortalities occurred. All animals exhibited clear, oily perineal staining on the 1st, 2nd, and 3rd day following treatment. This condition normally regarded as an adverse effect, was considered to be a consequence of the high dose level administered and not considered a toxic sign. No further clinical signs of toxicity were reported. The acute oral LD50 was found to be greater than 15000 mg/kg bw.

In summary, the oral LD50 of Fatty acids, C5-9 tetraesters with pentaerythritol is greater than 2000 mg/kg bw.

 

CAS 68424-31-7

The study conducted with Fatty acids, C5-10, esters with pentraerythritol (CAS No.68424-31-7) (Robinson, 1991) with limitations (reduced animal number), revealed but revealed no mortality and no other toxic effects, but an initial weight loss after treatment of rats with 2000 mg/kg bw. However this effect was completely reversible and the animals showed subsequently normal body weight gain.

Acute Inhalation Toxicity

CAS 68424-31-7

An acute inhalation toxicity study was performed with Fatty acids, C5-10, esters with pentraerythritol (CAS 68424-31-7) comparable to OECD Guideline 403. 5 male and female Alpk:APfSD rats were exposed for 4 hours to 5.0 mg/L test substance aerosol by nose only inhalation (Parr-Dobrzanski, 1994). The test substance caused no mortality, body weight changes or abnormalities in necropsy during the 15 day study period. Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for exposure. The LC50 was therefore found to be greater than 5.1 mg/L.

Acute Dermal Toxicity

CAS 71010-76-9

An acute dermal toxicity study (limit test) was performed on Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) comparable to OECD Guideline 402 and GLP (Mallory, 2006). 5 male and female Sprague-Dawley rats were exposed to 2000 mg test substance /kg bodyweight for 24 hours on the back skin under semiocclusive conditions. The observation period was 14 days. No clinical signs of systemic toxicity were noted in any animal during the study period. Body weight gain and necropsy at study termination revealed no abnormalities. Thus, the acute dermal LD50 in rats for Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid was found to exceed 2000 mg/kg bw.

Justification for classification or non-classification

All available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008.