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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 August 2000 - 5 September 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
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:
29 August 2000 - 5 September 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See attached justification in section 13.2
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA/Ca
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: A maximum of 4 mice was housed per cage, in cages suitable for animals of this strain and weight range.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3°C
- Humidity (%): 30-70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): Artificial, giving 12 hours light, 12 hours dark
Vehicle:
other: 25% ethanol/75% DEP
Concentration:
1%, 3%, 10%, 30% or 50% wlv
No. of animals per dose:
4
Details on study design:
A sample of Material D (DL hydroxycitronellal) was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines the level of T lymphocyte proliferation in the lymph nodes draining the site of chemical application, by measuring the amount of radiolabelled thymidine incorporated into the dividing cells. The test substance was applied as 1%, 3%, 10%, 30% or 50% wlv preparations in Material G (25% ethanon5% DEP). The estimated concentration giving rise to a 3 fold increase in lymphocyte proliferation was calculated (EC3).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
The application of hexylcinnamaldehyde at concentrations of I%, 3% and 10% wlv in acetone resulted in a greater than 3-fold increase in isotope incorporation at the 3% and 10% W/V concentrations. Therefore, hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
Parameter:
EC3
Test group / Remarks:
10%
Remarks on result:
other: not specified
Key result
Parameter:
EC3
Value:
19.33
Test group / Remarks:
30%
Key result
Parameter:
EC3
Value:
19.33
Test group / Remarks:
50%
Parameter:
SI
Test group / Remarks:
10%
Remarks on result:
other: not determined
Parameter:
SI
Test group / Remarks:
30%
Remarks on result:
other: not determined
Parameter:
SI
Test group / Remarks:
50%
Remarks on result:
other: not determined
Cellular proliferation data / Observations:
The application of the test item at concentrations of 1%, 3% 10%,30% and 50% wlv in vehicle resulted in an increase in isotope incorporation which was greater than 3-fold at the 30% and 50% wlv concentrations. Consequently, the test substnace in the vehicle was shown to be a potential skin sensitiser. The estimated concentration giving rise to a 3 fold increase in lymphocyte proliferation (EC3) was 19.33% wlv.

Animals were checked at least once for signs of systemic toxicity.

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
In conclusion, the test substance in 25% ethanol/75% DEP is a skin sensitiser under the conditions of the test, with an EC concentration of 19.33% wlv.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: A maximum of 4 mice was housed per cage, in cages suitable for animals of this strain and weight range.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3°C
- Humidity (%): 30-70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): Artificial, giving 12 hours light, 12 hours dark

Study design: in vivo (LLNA)

Vehicle:
other: 25% ethanol/75% DEP
Concentration:
1%, 3%, 10%, 30% or 50% wlv
No. of animals per dose:
4
Details on study design:
A sample of Material D (DL hydroxycitronellal) was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines the level of T lymphocyte proliferation in the lymph nodes draining the site of chemical application, by measuring the amount of radiolabelled thymidine incorporated into the dividing cells. The test substance was applied as 1%, 3%, 10%, 30% or 50% wlv preparations in Material G (25% ethanon5% DEP). The estimated concentration giving rise to a 3 fold increase in lymphocyte proliferation was calculated (EC3).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The application of hexylcinnamaldehyde at concentrations of I%, 3% and 10% wlv in acetone resulted in a greater than 3-fold increase in isotope incorporation at the 3% and 10% W/V concentrations. Therefore, hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
EC3
Value:
19.33
Test group / Remarks:
30%
Key result
Parameter:
EC3
Value:
19.33
Test group / Remarks:
50%
Parameter:
EC3
Test group / Remarks:
10%
Remarks on result:
other: not specified
Parameter:
SI
Test group / Remarks:
50%
Remarks on result:
other: not determined
Parameter:
SI
Test group / Remarks:
30%
Remarks on result:
other: not determined
Parameter:
SI
Test group / Remarks:
10%
Remarks on result:
other: not determined
Cellular proliferation data / Observations:
The application of the test item at concentrations of 1%, 3% 10%,30% and 50% wlv in vehicle resulted in an increase in isotope incorporation which was greater than 3-fold at the 30% and 50% wlv concentrations. Consequently, the test substnace in the vehicle was shown to be a potential skin sensitiser. The estimated concentration giving rise to a 3 fold increase in lymphocyte proliferation (EC3) was 19.33% wlv.

Any other information on results incl. tables

Animals were checked at least once for signs of systemic toxicity.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
In conclusion, the test substance in 25% ethanol/75% DEP is a skin sensitiser under the conditions of the test, with an EC concentration of 19.33% wlv.