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Diss Factsheets

Administrative data

Description of key information

The skin sensitisation potential of the test item is read-across from dilithium adipate. The skin sensitisation potential of dilithium adipate was determined in a LLNA study conducted according to OECD 429 and EU Method B.42 guidelines, and dilithium adipate was determined not to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 October 2015 to 26 October 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
2, 15 and 30 % test item w/w
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w

SCORE:
Erythema and eschar formation:
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) - 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema - 4
Positive control substance(s):
other: no
Positive control results:
A reliability check is carried out at regular intervals to check the sensitivity of the test system and the reliability of the experimental techniques used at the laboratory. The last check was performed in April 2015. The SI values calculated for the item concentrations 5, 10 and 25% were 1.7, 3.0 and 9.1 respectively. An EC3 value of 10% was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%. The results of the 6 monthly HCA reliability checks of the recent years were 16.5, 14.5, 13.4, 14.1, 17.3 and 9.8%. Based on the results, it was concluded that the Local Lymph Node Assay as performed at the laboratory is an appropriate model for testing for contact hypersensitivity.
Parameter:
SI
Value:
1
Test group / Remarks:
Test item concentration = 2%
Parameter:
SI
Value:
0.9
Test group / Remarks:
Test item concentration = 15%
Parameter:
SI
Value:
0.6
Test group / Remarks:
Test item concentration = 30%
Parameter:
EC3
Value:
> 30

No irritation and no signs of systemic toxicity were observed in any of the animals.

No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.

No macroscopic abnormalities of the surrounding area were noted for any of the animals.

Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.

Interpretation of results:
GHS criteria not met
Conclusions:
Dilithium adipate would not be regarded as a skin sensitizer.
Executive summary:

This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
07 October 2015 to 26 October 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Source and target substances are likely to dissociate after administration into metals ions and fatty acids due to the ionic bond between the metal cation and fatty acid ion being disrupted by polar aqueous media. The fatty acid component is not expected to be hazardous as it is potentially exempt from REACH under Annex V. The main difference between source and target substances is the cation and therefore test organisms would be exposed to either calcium from the target substance or lithium from the source substance. Although the cations are different, read across from lithium adipate is considered to be appropriate for in vitro genetic toxicity and skin sensitisation as both lithium and calcium show a similar lack of toxicity for these endpoints. Further information is included in the read-across justification attached to Section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
2, 15 and 30 % test item w/w
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w

SCORE:
Erythema and eschar formation:
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) - 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema - 4
Positive control substance(s):
other: No
Positive control results:
A reliability check is carried out at regular intervals to check the sensitivity of the test system and the reliability of the experimental techniques used at the laboratory. The last check was performed in April 2015. The SI values calculated for the item concentrations 5, 10 and 25% were 1.7, 3.0 and 9.1 respectively. An EC3 value of 10% was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%. The results of the 6 monthly HCA reliability checks of the recent years were 16.5, 14.5, 13.4, 14.1, 17.3 and 9.8%. Based on the results, it was concluded that the Local Lymph Node Assay as performed at the laboratory is an appropriate model for testing for contact hypersensitivity.
Parameter:
SI
Value:
1
Test group / Remarks:
Test item concentration = 2%
Parameter:
SI
Value:
0.9
Test group / Remarks:
Test item concentration = 15%
Parameter:
SI
Value:
0.6
Test group / Remarks:
Test item concentration = 30%
Parameter:
EC3
Value:
> 30

No irritation and no signs of systemic toxicity were observed in any of the animals.

No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.

No macroscopic abnormalities of the surrounding area were noted for any of the animals.

Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.

Interpretation of results:
GHS criteria not met
Conclusions:
Dilithium adipate would not be regarded as a skin sensitizer.
Executive summary:

This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The source and target substances are likely to dissociate after administration into metals ions and fatty acids due to the ionic bond between the metal cation and fatty acid ion being disrupted by polar aqueous media. The fatty acid component is not expected to be hazardous as it is potentially exempt from REACH under Annex V. The main difference between source and target substances is the cation and therefore test organisms would be exposed to either calcium from the target substance or lithium from the source substance. Although the cations are different, read across from lithium adipate is considered to be appropriate for skin sensitisation as both lithium and calcium show a similar lack of toxicity for this endpoint.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification is required for calcium dioctanoate based on read across from dilithium adipate. The stimulation index was <3 in an LLNA study conducted with dilithium adipate.