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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin Sensitization:

Based on all the available data, it was concluded that the test chemical is not likely to cause any sensitizing reactions on tested species and therefore is not likely to classify as a 'skin sensitizer' as per the CLP criteria of classification and labeling.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report
Qualifier:
equivalent or similar to guideline
Guideline:
other: Human Maximization Test
Principles of method if other than guideline:
To evalute skin sensitization potential of the test chemical in human for 12 days study period.
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
Not specified
Species:
other: Human
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
No data available
Route:
other: no data
Vehicle:
water
Concentration / amount:
5% aqueous solution
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
No.:
#1
Route:
other: no data
Vehicle:
water
Concentration / amount:
5 % aqueous solution
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
207 human volunteers
Details on study design:
induction phase of applications three times per week for three weeks was followed 12 days later by a challenge application
Challenge controls:
Not specified
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
207
Clinical observations:
No local reactions of sensitisation was seen in 207 human volunteers
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not sensitizing
Conclusions:
No local reactions (irritation or sensitisation) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance was non sensitization to human skin.
Executive summary:

The skin sensitization potential of the test chemical was evaluated on 207 human volunteers. The test chemical was used in the concentration 5% in aqueous solution. Induction phase was subjected three times per week for three weeks which was followed by challenge application after 12 days. No local reactions (irritation or sensitization) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance  was non sensitization to human skin.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assesment report
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
According to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
No data available
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0.5 – 4% in dimethylsulfoxide and in acetone/aqua (1:1) i.e. AA mixed with olive oil (4:1)
No. of animals per dose:
50 females, divided into 10 groups of 5 animals
Details on study design:
On days 0, 1 and 2 the animals received 25 μl of one of the test preparations or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting.
Positive control substance(s):
not specified
Statistics:
The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated
Positive control results:
No data available
Parameter:
SI
Value:
> 3
Test group / Remarks:
The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated
Remarks on result:
other: not sensitizing
Cellular proliferation data / Observations:
The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated.
Interpretation of results:
other: Not sensitizing
Conclusions:
The stimulation indices for the test chemical were less than 3 at all tested concentrations, hence an EC3 value could not be calculated. Therefore, the test chemical was considered to be not sensitizing to skin of mice.
Executive summary:

Mouse local lymph node assay (LLNA) was performed to determine the allergic potential of the test chemical. The study was performed as per OECD Guidelines 429. 50 CBA:J female mice, divided into 10 groups of 5 animals were used for the study. On days 0, 1 and 2 the animals received 25 μl of one of the test chemical or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting. The stimulation indices for the test chemical were less than 3 at all tested concentrations, hence an EC3 value could not be calculated. Therefore, the test chemical was considered to be not sensitizing to skin of mice.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report
Qualifier:
according to guideline
Guideline:
other: Human maximization test
Principles of method if other than guideline:
Human maximization test was performed to evaluate skin sensitization potential of the test chemical on 207 human volunteers
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
Not specified
Species:
other: Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
207 human volunteers were used
Parameter:
SI
Value:
0
Remarks on result:
other: Not sensitizing
Cellular proliferation data / Observations:
No skin irritation or reaction was observed
Interpretation of results:
other: Not sensitizing
Conclusions:
The test chemical was applied on 207 human volunteers in the concentration 5% aqueous solution. No skin reaction was observed. Hence, the test chemical was considered to be not sensitizing to humans.
Executive summary:

Human maximization test was performed to evaluate skin sensitization potential of the test chemical on 207 human volunteers

The test chemical was tested with daily skin applications of 5 % aqueous solution. An induction phase of applications three times per week for three weeks was followed 12 days later by a challenge application. No skin reaction was observed. Hence, the test chemical was considered to be not sensitizing to humans.

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

Skin Sensitization:

Various studies have been summarized to evaluate the allergic potential of the test chemical in living organisms. These include in vivo experimental studies on humans, mice for the test chemicals. They are summarized as follows:

 

The skin sensitization potential of the test chemical was evaluated on 207 human volunteers.

The test material was used in the concentration 5% in aqueous solution. Induction phase was subjected three times per week for three weeks which was followed by challenge application after 12 days.

No local reactions (irritation or sensitization) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance  was non sensitization to human skin.

 

This is supported by a Mouse local lymph node assay (LLNA) performed to determine the allergic potential of the test chemical. The study was performed as per OECD Guidelines 429. 50 CBA: J female mice, divided into 10 groups of 5 animals were used for the study. On days 0, 1 and 2 the animals received 25 μl of one of the test chemical or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting. The stimulation indices for the test chemical were less than 3 at all tested concentrations, hence an EC3 value could not be calculated. Therefore, the test chemical was considered to be not sensitizing to skin of mice.

 

The above results are supported by a human maximization test was performed to evaluate skin sensitization potential of the test chemical on 207 human volunteers. The test chemical was tested with daily skin applications of 5 % aqueous solution. An induction phase of applications three times per week for three weeks was followed 12 days later by a challenge application. No skin reaction was observed. Hence, the test chemical was considered to be not sensitizing to humans.

 

Available results for the test chemical indicate a strong possibility that the test chemical may not be able to cause any reactions to the skin. Hence, the test chemical can be considered to be not sensitizing to skin and classified under the category “Not Classified” as per CLP Regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Available results for the test chemical indicate a strong possibility that the test chemical may not be able to cause any reactions to the skin. Hence, the test chemical can be considered to be not sensitizing to skin and classified under the category “Not Classified” as per CLP Regulation.