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Description of key information

There are no reliable studies available for the assessment of the skin sensitisation endpoint with the target substance,Polyol TD. Therefore, data from suitable read-across partners, 2-ethylpropane1,3-diol (DMP) and 5-Ethyl-1,3-dioxane-5-methanol (CTF)was used to assess the skin sensitisation potential of the target substance. For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

The results of local lymph node assays performed according to OECD Guideline 429 with both source substances did not indicate a skin sensitising potential of DMP and CTF. It is therefore concluded that the target substance Polyol TD is not 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Positive control results:
The stimulation indices in a recent positive control study were 1.7, 2.4 and 5.0 for 5%, 10% and 25% hexyl cinnamic aldehyde, respectively.
Parameter:
SI
Value:
0.9
Test group / Remarks:
low dose (25% test substance)
Parameter:
SI
Value:
0.8
Test group / Remarks:
mid dose (50% test substance)
Parameter:
SI
Value:
1.7
Test group / Remarks:
high dose (100% test substance)
Parameter:
other: disintegrations per minute (DPM)
Value:
3 136
Test group / Remarks:
0% (vehicle control)
Parameter:
other: disintegrations per minute (DPM)
Value:
2 763
Test group / Remarks:
low dose (25% test substance)
Parameter:
other: disintegrations per minute (DPM)
Value:
2 642
Test group / Remarks:
mid dose (50% test susbtance)
Parameter:
other: disintegrations per minute (DPM)
Value:
5 471
Test group / Remarks:
high dose (100% test substance)
Cellular proliferation data / Observations:
Preliminary study: No systemic signs and no signs of local irritation were noted in either animal receiving undiluted DMP tech. Body weights were considered to be acceptable for mice of this age and strain. Based on these findings, a 100% concentration of DMP tech (i.e. undiluted DMP tech) was selected as the highest concentration for the main study.

Main study: No systemic signs were noted in any animal during the observation period. Body weight gains were considered to be acceptable for mice of this age and strain.

Table 1: Individual and Group Mean Scintillation Counts

Treatment

Animal No.

DPM

Group Mean DPM

Stimulation Index

Vehicle control (dimethylformamide)

1

3720

3136

1

2

2595

3

2755

4

3697

5

2911

DMP Tech 25%

6

3086

2763

0.9

7

3375

8

495

9

2607

10

4254

DMP Tech 50%

11

3367

2642

0.8

12

1394

13

1891

14

2210

15

4349

DMP Tech 100%

16

6835

5471

1.7

17

5531

18

7050

19#

902

20

2468

DPM – disintegrations per minute

DMP Tech – Dimethylolpropane Tech

# DPM value excluded from mean owing to spillage

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, since treatment with Dimethylolpropane Tech at concentrations of up to 100% (i.e. undiluted Dimethylolpropane tech) did not achieve a stimulation index of ≥3, it was considered that the test item does not have the potential to cause sensitisation.
Executive summary:

In a dermal sensitisation study (according to OECD Guideline 429) with Dimethylolpropane Tech (DMP tech) in dimethylformamide at concentrations of 25%, 50% and 100%, 5 female CBA/Ca mice per dose were tested for 3 consecutive days in the Local Lymph Node Assay. Hexy cinnamic aldehyde (CAS No. 101-86-0) served as a postive control and induced the appropriate response. Dimethylformamide was included as a vehicle control in one group of 5 females.

There were no systemic signs noted in any animal during the observation period and body weight changes were considered to be acceptable for mice of this age and strain. The stimulation index (SI) values for mice treated with DMP tech at concentrations of 25%, 50% or 100%, when compared with the control group, were 0.9, 0.8 and 1.7, respectively. Under the conditions of the study, treatment with Dimethylolpropane Tech at concentrations of up to 100% (i.e. undiluted Dimethylolpropane Tech) did not achieve a stimulation index of ≥3, therefore it was considered that the test item is not a dermal sensitiser.

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Positive control results:
The stimulation indices in a recent positive control study were 1.7, 2.4 and 5.0 for 5%, 10% and 25% hexylcinnamicaldehyde, respectively.
Parameter:
SI
Value:
0.9
Test group / Remarks:
low dose (25% test substance)
Parameter:
SI
Value:
0.9
Test group / Remarks:
mid dose (50% test substance)
Parameter:
SI
Value:
1.2
Test group / Remarks:
high dose (100% test substance)
Parameter:
other: disintegrations per minute (DPM)
Value:
1 750
Test group / Remarks:
0% (vehicle control)
Parameter:
other: disintegrations per minute (DPM)
Value:
1 580
Test group / Remarks:
low dose (25% test substance)
Parameter:
other: disintegrations per minute (DPM)
Value:
1 536
Test group / Remarks:
mid dose (50% test substance)
Parameter:
other: disintegrations per minute (DPM)
Value:
2 157
Test group / Remarks:
high dose (100% test substance)
Cellular proliferation data / Observations:
Preliminary test: No systemic signs and no signs of local irritation were noted in either animal receiving undiluted CTF. Body weight gain was considered to be acceptable for mice of this age and strain. Based on these findings, a 100% concentration of CTF (i.e. undiluted CTF) was selected as the highest concentration for the main study.

Main study: No systemic signs were noted in any animal during the observation period. Body weight gains were considered to be acceptable for mice of this age and strain.

Table 1: Individual and Group Mean Scinitillation Counts (DPM)

Treatment

Animal No.

DPM

Group Mean DPM

Stimulation Index

Vehicle control (dimethylformamide)

1

1085

1750

1

2

2062

3

2507

4

1687

5

1410

CTF 25%

6

688

1580

0.9

7

3134

8

1221

9

1616

10

1243

CTF 50%

11

1588

1536

0.9

12

1407

13

2341

14

977

15

1365

CTF 100%

16

1749

2157

1.2

17

1819

18

1504#

19

1863

20

3198

DPM – disintegrations per minute

CTF – cyclic trimethylolpropane formal

# Animal 18 excluded from group mean because only one lymph node was obtained

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, since treatment with cyclic trimethylolpropane formal (CTF) at concentrations of up to 100% (i.e. undiluted cyclic trimethylolpropane formal) did not achieve a stimulation index of ≥3, it was considered that the test item does not have the potential to cause sensitisation.
Executive summary:

In a dermal sensitisation study (according to OECD Guideline 429) with cyclic trimethylolpropane formal (CTF) in dimethylformamide at concentrations of 25%, 50% and 100%, 5 female CBA/Ca mice per dose were tested for 3 consecutive days in a Local Lymph Node Assay. Hexy cinnamic aldehyde (CAS No. 101-86-0) served as a postive control and induced the appropriate response. Dimethylformamide was included as a vehicle control in one group of 5 females. There were no systemic signs noted in any animal during the observation period and body weight changes were considered to be acceptable for mice of this age and strain. The stimulation index (SI) values for the mice treated with CTF at concentrations of 25%, 50% or 100%, when compared with the control group, were 0.9, 0.9 and 1.2, respectively.

Under the conditions of the study, treatment with cyclic trimethylolpropane formal at concentrations of up to 100% (i.e. undiluted cyclic trimethylolpropane formal) did not achieve a stimulation index of ≥3, therefore it was considered that the test item is not a dermal sensitiser.

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the attached read-across report (see IUCLID section 13).

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

Two GLP studies were conducted, to determine the skin sensitisation potential of Cyclic trimethylolpropane (CTF) and Dimethylolpropane Tech (DMP Tech) (Robinson, 2010) using the local lymph node assay (according to OECD Guideline 429). Under the conditions of the studies, since treatment with DMP Tech or CTF at concentrations of up to 100% did not achieve stimulation index values of ≥3, it was considered that the test items did not have the potential to cause sensitisation. Furthermore, other component TMP of the target substance is also not considered to be a skin sensitiser, based on read-across from DMP.

There is no evidence from experience of use that the target substance or its components has the potential to cause skin sensitisation in exposed workers.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No animal data are available. There is no evidence from experience of use that the substance or its components has the potential to cause respiratory sensitisation in exposed workers.


Justification for classification or non-classification

Based on the available data,classification for skin sensitisation according to the CLP Regulation 1272/2008 is not warranted.