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Diss Factsheets

Administrative data

Description of key information

In an acute oral limit test in rats with C9-11 branched alcohols, C10 rich diesters with nonanedioic acid no mortality/toxicity was observed at 2000 mg/kg bw. The LD50 is > 2000 mg/kg bw (Bien 1993).

For bis(2-ethylhexyl) azelate an oral LD50 of > 2000 mg/kg bw was found (Shirota 2003).

In an acute dermal limit test in rats with C9-11 branched alcohols, C10 rich diesters with nonanedioic acid no mortality/toxicity was observed at 2000 mg/kg bw. The LD50 is > 2000 mg/kg bw (van Otterdijk 2010).

For bis(2-ethylhexyl) azelate a dermal LD50 of 18300 mg/kg bw (20 ml/kg bw) was found in rabbits (Smyth 1962).

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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
- Details on strain: Crj:CD(SD)IGS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 5 weeks
- Fasting period before study: from 4 pm one day before administration to 3 hours after administration
- Diet: CRF-2 (CLEA Japan, Meguro, Japan), ad libitum except fasting period
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 24
- Humidity (%): 50.5 - 62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
Doses:
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: animals were observed hourly up to 6 h post administration and once daily thereafter (including
weekends and holidays), and individual body weights were determined on Day 1, 2, 4, 8, 11 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Student's t- test, Aspin-Welch test
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:
other: Soft faeces were observed in control groups of both sexes after 1 to 6 hours of administration. But no other clinical signs were evident in male and female rats.
Gross pathology:
Cysts in right kidney were found in one male of control group. But no other abnormal changes were noted at necropsy in other males and females.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 Nov - 29 Nov 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions (test substance purtiy not given)
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
, lack of details on test substance
GLP compliance:
yes (incl. QA statement)
Remarks:
Niedersächsisches Umweltministerium, Hannover, Germany
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Bor: WISW (SPF cbp)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: males: 222-240 g, females: 161-181 g
- Fasting period before study: from 16 h before until 3-4 h after administration
- Housing: up to 5 animals per Makrolon type III cage on sterilised soft wood bedding.
- Diet: Ssniff-R Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 9 - 29 Nov 1993
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.17 mL/kg bw
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: 10 min, 1, 2, 6 and 24 h after application. Thereafter once daily.
- Frequency of weighing: On days 0, 7 and 14 p.a.
- Necropsy of survivors performed: yes, on all animals on day 14.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: No abnormal clinical signs were observed.
Gross pathology:
No test-item dependent findings were noted.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
based on studies with two structural analogues

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles. (Whole trunk was clipped for test substance application, only 4 animals used in test group, no data on clinical signs, mortality, body weight and gross pathology.)
Principles of method if other than guideline:
Rabbits were exposed dermally to the test substance for 24 hours.
GLP compliance:
no
Test type:
standard acute method
Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: entire trunk
- Type of wrap if used: impervious plastic film

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): up to 20 mL/kg bw

Duration of exposure:
24 hours
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- during 24 hours exposure period animals are immobilized, during observation period animals are caged
- Duration of observation period following administration: 14 days
Statistics:
LD50 value was calculated by the method of Thompson (Bacteriol. Rev. 11: 115, June 1947) using the tables of Weil (Biometrics, 8: 249, Sept. 1952).
Sex:
male
Dose descriptor:
LD50
Effect level:
20 mL/kg bw
Based on:
test mat.
95% CL:
9.1 - 43.8
Sex:
male
Dose descriptor:
LD50
Effect level:
18 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: recalculated value with a density of 915 mg/mL at 25 °C (Lide, 2005)

No data on mortality or clinical signs is given, body weight and gross pathology were not covered in this study

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified
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: Guideline study with acceptable restrictions; analytical purity of test material not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
analytical purity of test material not specified
GLP compliance:
yes
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: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 11-12 weeks
- Weight at study initiation: mean for males 323 g, mean for females 210 g, body weight variation did not exceed ± 20% of the sex mean
- Housing: individually housed in labeled Macrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 05 Jan 2010 To: 19 Jan 2010
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 25 cm² for males and 18 cm² for females
- % coverage: 10
- Type of wrap if used: surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage, a piece of Micropore tape was additionally used for fixation of the bandages in females only

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed with tap water.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.20 mL/kg bw



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: Mortality/Viability: Twice daily; Body weights: Days 1 (pre-administration), 8 and 15; Clinical signs: at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: Flat posture and/or chromodacryorrhoea was observed among several animals on Day 1. Scales were seen in the treated skin-area of several animals between Days 4 and 13.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
based on studies with two structural analogues

Additional information

Based on the information on the analogue substances and in view of the similarities of the components (and the starting materials) of the source and target chemicals the oral and dermal LD50 values for diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid are >2000 mg/kg bw (see attached rationale for read-across section 13).

Justification for classification or non-classification

Based on the outcome of the available studies on the analogue substances, no classification for diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid is considered according to EC No 1272/2008.