Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating

RA from source substance Ditridecyl adipate (CAS 16958 -92 -2)

Eye irritation (similar to OECD 405): not irritating

RA from source substance Ditridecyl adipate (CAS 16958 -92 -2)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 - 05 Oct 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP - Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24 Apr 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
Species:
rabbit
Strain:
other: New Zealand White (Hsdlf:NZW)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 2.59 - 2.61 kg
- Housing: Animals were individually housed in suspended cages, provided with environmental enrichment items.
- Diet: 2930C Teklad Global Certified Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
1 male and 1 female
Details on study design:
TEST SITE
- Area of exposure: The test substance was applied directly to the skin of the back of each rabbit under a 2.5 cm x 2.5 cm cotton gauze patch.
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape and the trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Very slight erythema (grade 1) was noted in 1 animal at the 24 h reading, which was fully reversible 48 h after treatment.
Other effects:
No further local or systemic effects were observed.
Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Only basic data given. Report was limited, study was not GLP conform. Purity of test substance not given. No information given on amount / concentration applied.
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Act Regulations (16 CFR 1500.42)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2 October 2012
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Controls:
other: the untreated eye served as control
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
readings at 24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: washing used if fluorescein staining is used at 24 h reading time point
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The test material produced no corneal, iridial or conjunctival effects in any of the animals.
Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Irritation / corrosion

Justification for read-across

There are no data for irritation / corrosion available for Fatty acids, C18 -unsaturated, 1,6 Hexanediol Diester. To fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.1 and 8.2, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.

For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

As no experimental/measured data are available on skin and eye irritation/corrosion potency of Fatty acids, C18 -unsaturated, 1,6 Hexanediol Diester, read-across to reliable data on the analogue substance Ditridecyl adipate (CAS 16958-92-2) was conducted.

Skin Irritation

CAS 16958-92-2

The skin irritation properties of the test substance were tested in a study according to OECD 404 and in compliance with GLP (Sanders, 2012). Two rabbits (male and female) were exposed to 0.5 mL of the unchanged test material for 4 h (semiocclusive conditions). The observation period was 72 h including readings after 1, 24, 48 and 72 h. Very slight erythema (grade 1) was noted in 1/2 animals at the 24 h reading, which was fully reversible 48 h after treatment. No edema was observed.

Therefore, the test substance is not regarded as skin irritant.

 

Eye irritation

CAS 16958-92-2

The eye irritation potential of the test substance was determined by an in vivo eye irritation test similar to OECD 405 (Moldovan, 1973). Application of the test substance (no information on amount given) to six rabbit eyes for 24 h produced no corneal, iridial or conjunctival effects in any of the animals during the observation period of 72 h (including readings after 24, 48 and 72 h). Thus, the test substance is considered not to be irritant to the eye.

 

Conclusion on skin and eye irritation properties

Reliable data available for the read-across analogue substance indicate no irritating or corrosive property on the skin or eye as no adverse effects at the applied doses have been observed. Thus, as the available data did not identify any hazard for skin and eye irritation / corrosion, Fatty acids, C18 -unsaturated, 1,6 Hexandiol Diester is not considered as skin or eye irritant.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on irritation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.