Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No specific testing was performed on the reaction mass. However, the main components of the reaction mass were found to be not skin sensitizers. Therefore the reaction mass is also not a skin sensitizer.

Skin sensitisation

DEGDB:

- Key study, reliabiltiy 1, OECD 406, guinea pigs - not sensitising

DPGDB:

- Key study, reliabiltiy 1, OECD 406, guinea pigs - not sensitising

TEGDB:

- Key study, reliabiltiy 1, OECD 406, guinea pigs - not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 July 1997 - 22 August 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with EPA, EC and OECD test guidelines, and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Notification Yakushin 1 No. 24 11 September 1989, Pharmaceutical Affairs Bureau, MOHW "Skin Sensitization Tests".
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted long before the LLNA existed and the requirement was present
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: Approximately four to seven weeks
- Weight at study initiation: 316 - 436 g
- Housing: Housed in groups of five in suspended metal cages with wire mesh floors.
- Diet: Vitamin C enriched guinea-pig diet FD2 was provided ad libitum.
- Water: mains drinking water provided ad libitum.
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 28.5°C
- Humidity (%): 44 to 66%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light per 24 hour period.

IN-LIFE DATES: From: 23 July 1997 To: 22 August 1997
Route:
intradermal and epicutaneous
Vehicle:
other: None for induction injection and application; Alembicol D for the challenge application.
Concentration / amount:
Used as supplied for topical and intradermal injection induction exposures; Used as supplied and as 50% (v/v) in Alembicol D for the topical challenge exposure.
Route:
epicutaneous, semiocclusive
Vehicle:
other: None for induction injection and application; Alembicol D for the challenge application.
Concentration / amount:
Used as supplied for topical and intradermal injection induction exposures; Used as supplied and as 50% (v/v) in Alembicol D for the topical challenge exposure.
No. of animals per dose:
20 for test substance group and test substance vehicle control group; 10 for positive control group and vehicle control group to positive control group.
Details on study design:
RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the topical route of administration for the challenge phase. Animals for these investigations were pre treated with an intradermal injection of Freund's complete adjuvant (FCA) 50:50 with water for irrigation (Ph Eur) at least one week prior to the start of the preliminary investigations.

The procedure employed for these investigations was as follows:

Intradermal injections - Intradermal injections (0.1 mL/site) were made into the clipped flank of a total of four guinea pigs, using a range of concentrations of the test material in a suitable vehicle. As no adverse reactions were observed for the first two guinea pigs receiving concentrations 0.1 - 10% v/v, further concentrations (20-100% v/v) were investigated. The resulting dermal responses were assessed approximately 24 and 72 hours later.

Topical application - Approximately 0.5 mL of each of a range of concentrations of the test substance in a suitable vehicle was applied to patches of surgical gauze (20 x 20mm). These were placed on the clipped and shaved flanks of each of four guinea pigs. The patches were covered by a strip of "Blenderm" and firmly secured by "Elastoplast" wound round the trunk and covered with "Sleek impervious" plastic adhesive tape. After an exposure period of approximately 6 hours, the dressings were removed and the reaction sites were assessed for erythema and oedema on a numerical basis according to the system given. Further examination ofthe sites was carried out approximately 24 and 48 hours after removal of the dressings.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (One by intradermal injections, one by topical application)
- Exposure period: 8 days (6 days following injections plus two days following dermal application).
- Test groups: 1)FCA in water (50/50 v/v); 2) Test substance as supplied; 3) Test substance in FCA (50/50 v/v).
- Control group: Vehicle control for test substance, Positive control (hexyl cinnamic aldehyde (HCA)), Vehicle control for positive control.
- Site: Scapular region
- Frequency of applications: As noted above.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: One day, two weeks after topical induction.
- Exposure period: 24 hours
- Test groups: Test group and vehicle control group were exposed to 0.2 mL test substance and 0.2 mL test substance in Alembicol D (50% v/v).
- Control group: Positive control groups were exposed to HCA and HCA 50% in Alembicol D
- Site: Test substance or HCA as supplied was applied to an anterior site; test substance or HCA in Alembicol D was applied to the posterior site.
- Evaluation (hr after challenge): 24 and 48
Positive control substance(s):
yes
Remarks:
Hexyl Cinnamic Aldehyde
Positive control results:
Dermal reactions were seen in all ten test animals compared to none in the controls. Therefore all ten test animals gave positive responses.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 mL, material as supplied or 50% in Alembicol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
no indication of skin sensitisation
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded..
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 mL, material as supplied or 50% in Alembicol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
no indication of skin sensitisation
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded..
Key result
Reading:
other: All animals
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
moderate erythema
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other:
Hours after challenge:
24
Group:
negative control
Dose level:
50:50 FCA and water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
None
Interpretation of results:
other:
Remarks:
EU-GHS criteria not met
Conclusions:
In this study, DEGDB did not produce evidence of skin sensitization (delayed contact hypersentisivity) in any of the twenty test animals.
Evidence of skin sensitization was produced by hexyl cinnamic aldehyde (HCA) in all of the ten positive control test animals thus confirming the sensitivity of the method.
Executive summary:

A study was performed to determine the potential for skin sensitization to guinea pigs of the test substance DEGDB. The study was conducted according to EPA, OECD and EC test guidelines, and in compliance with GLP. Evidence of skin sensitization was seen in all animals treated by the positive control substance, Hexyl cinnamic aldehyde, confirming the sensitivity of the method. DEGDB did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the animals tested.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 July 1997 - 22 August 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordince with EPA, EC and OECD test guidelines and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Notification Yakushin 1 No. 24 11 September 1989, Pharmaceutical Affairs Bureau, MOHW "Skin Sensitization Tests".
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA was not a validated study at the time this test was conducted
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D Hall, Newchurch, Staffordshire, England
- Age at study initiation: Approximately 4 to 7 weeks
- Weight at study initiation: 325 to 438 g
- Housing: Housed in groups of five in suspended metal cages with wire mesh floors.
- Diet: Vitamin C enriched guinea pig diet FD2 was provided ad libitum. Hay was given weekly.
- Water: drinking water providede ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 28.5°C
- Humidity (%): 44 to 66%
- Air changes (per hr): 15
- Photoperiod: 12 hours light per 24 hour period

IN-LIFE DATES: From: 23 July 1997 To: 22 August 1997
Route:
intradermal and epicutaneous
Vehicle:
other: None for induction injection and application; Alembicol D for the challenge application.
Concentration / amount:
Used as supplied for topical and intradermal injection induction exposures; Used as supplied and as 50% (v/v) in Alembicol D for the topical challenge exposure.
Route:
epicutaneous, semiocclusive
Vehicle:
other: None for induction injection and application; Alembicol D for the challenge application.
Concentration / amount:
Used as supplied for topical and intradermal injection induction exposures; Used as supplied and as 50% (v/v) in Alembicol D for the topical challenge exposure.
No. of animals per dose:
20 for test substance group and test substance vehicle control group; 10 for positive control group and vehicle control group to positive control group.
Details on study design:
RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the topical route of administration for the challenge phase. Animals for these investigations were pre treated with an intradermal injection of Freund's complete adjuvant (FCA) 50:50 with water for irrigation (Ph Eur) at least one week prior to the start of the preliminary investigations.

The procedure employed for these investigations was as follows:
Intradermal injections - Intradermal injections (0.1 mL/site) were made into the clipped flank of a total of four guinea pigs, using a range of concentrations of the test material in a suitable vehicle. As no adverse reactions were observed for the first two guinea pigs receiving concentrations 0.1 - 10% v/v, further concentrations (20-100% v/v) were investigated. The resulting dermal responses were assessed approximately 24 and 72 hours later.

Topical application - Approximately 0.5 mL of each of a range of concentrations of the test substance in a suitable vehicle was applied to patches of surgical gauze (20 x 20mm). These were placed on the clipped and shaved flanks of each of four guinea pigs. The patches were covered by a strip of "Blenderm" and firmly secured by "Elastoplast" wound round the trunk and covered with "Sleek impervious" plastic adhesive tape. After an exposure period of approximately 6 hours, the dressings were removed and the reaction sites were assessed for erythema and oedema on a numerical basis according to the system given. Further examination ofthe sites was carried out approximately 24 and 48 hours after removal of the dressings.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (One by intradermal injections, one by topical application)
- Exposure period: 8 days (6 days following injections plus two days following dermal application).
- Test groups: 1) FCA in water (50/50 v/v); 2) Test substance as supplied; 3) Test substance in FCA (50/50 v/v).
- Control group: Vehicle control for test substance, Positive control (hexyl cinnamic aldehyde (HCA)), Vehicle control for positive control.
- Site: Scapular region
- Frequency of applications: As noted above.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: One day, two weeks after topical induction.
- Exposure period: 24 hours
- Test groups: Test group and vehicle control group were exposed to 0.2 mL test substance and 0.2 mL test substance in Alembicol D (50% v/v).
- Control group: Positive control groups were exposed to HCA and HCA 50% in Alembicol D
- Site: Test substance or HCA as supplied was applied to an anterior site; test substance or HCA in Alembicol D was applied to the posterior site.
- Evaluation (hr after challenge): 24 and 48

Challenge controls:
The control and test animals were challenged topically two weeks after the topical induction application using Benzoflex 9- 88 as supplied and 50% v/v in Alembicol D.
Positive control substance(s):
yes
Remarks:
Hexyl cinnamic aldehyde
Positive control results:
Evidence of skin sensitization was produced by hexyl cinnamic aldehyde (HCA) in all ten test animals thus confirming sensitivity of this test method.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 mL, material as supplied or 50% in Alembicol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 mL, material as supplied or 50% in Alembicol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded..
Key result
Reading:
other: mean
Group:
positive control
Dose level:
10% amd 50%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Erythema and edema
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other:
Group:
negative control
Dose level:
50:50 FCA and water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other:
Remarks:
EU-GHS criteria not met
Conclusions:
In this study DPGDB did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the twenty test animals.
Evidence of skin sensitization was produced by hexyl cinnamic aldehyde (HCA) in all of the ten positive control test animals thus confirming the sensitivity of the method.
Executive summary:

A study was performed to assess the skin sensitization potential of the test substance DPGDB to guinea pigs. The study was conducted in accordance with OECD, EC and US EPA test guidelines, and in compliance with GLP.

The test substance was used as supplied for topical and intradermal injection induction exposures and as supplied and as a 50% (v/v) solution in Alembicol D for topical challenge exposure. Hexyl cinnamic aldehyde was used as positive control.

Evidence of skin sensitization was seen in all animals treated with this substance, but no reactions were observed in the control group, confirming the sensitivity of the method.  No evidence of toxicity or ill health were recorded for any animal exposed to the test substance. There were no dermal reactions seen in any of the test animals, therefore all these animals gave negative responses.

DPGDB did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the animals tested.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 July 1997 - 23 August 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with EPA, EC and OECD test guidelines, and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Notification Yakushin 1 No 24 11 September 1989 Pharmaceutical Affairs Bureau MOHW "Skin Sensitization Tests "
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted long before the LLNA was a valid method.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordhire, England
- Age at study initiation: Approximately four to seven weeks
- Weight at study initiation: 355 to 450g
- Housing: Housed in groups of five in suspended metal cages with wire mesh floor
- Diet: Vitamin C enriched guinea pig diet FD2 was provided ad libitum; hay was given weekly
- Water: mains drinking water provided ad libitum
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22°C
- Humidity (%): 45 - 61%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per 24 hour period

IN-LIFE DATES: From: 23 July 1997 To: 23 August 1997
Route:
intradermal and epicutaneous
Vehicle:
other: None for induction injection and application; Alembicol D for the challenge application.
Concentration / amount:
Used as supplied for topical and intradermal injection induction exposures; Used as supplied and as 50% (w/v) in Alembicol D for the topical challenge exposure.
Route:
epicutaneous, occlusive
Vehicle:
other: None for induction injection and application; Alembicol D for the challenge application.
Concentration / amount:
Used as supplied for topical and intradermal injection induction exposures; Used as supplied and as 50% (w/v) in Alembicol D for the topical challenge exposure.
No. of animals per dose:
20 for test substance group and test substance vehicle control group; 10 for positive control group and vehicle control group to positive control group.
Details on study design:
RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible
(a) concentrations of the test substance that would produce irritation suitable for the induction phase ofthe main study and
(b) amaximum non irritant concentration by the topical route of administration for the challenge phase. Animals for these investigations were pre-treated with an intradermal injection of Freund's complete adjuvant (FCA) 50:50 with water for irrigation (Ph Eur) at least one week prior to the start of the preliminary investigations

The procedure employed for these investigations was as follows:
Intradermal injections - Intradermal injections 0.1 mL/site were made into the clipped flank of a total of four guinea pigs using a range ofconcentrations of the test material in a suitable vehicle. As no adverse reactions were observed for the first two guinea pigs receiving concentrations 0.1 - 10 (v/v) further concentrations (20-100(v/v) were investigated. The resulting dermal responses were assessed approximately 24 and 72 hours later.

Topical application - Approximately 0.5 mL of each of a range of concentrations of the test substance in a suitable vehicle was applied to patches of surgical gauze (20 x 20 mm). These were placed on the clipped and shaved flanks ofeach of four guinea pig.s The patches were covered by a strip of "Blenderm" and firmly secured by "Elastoplast" wound round the trunk and covered with "Sleek" impervious plastic adhesive tape. After an exposure period of approximately 6 hours, the dressings were removed and the reaction sites were assessed for erythema and oedema on anumerical basis according to the system given. Further examination of the sites was carried out approximately 24 and 48 hours after removal ofthe dressings

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (One by intradermal injections, one by topical application)
- Exposure period: 8 days (6 days following injections plus two days following dermal application).
- Test groups: 1)FCA in water (50/50 v/v); 2) Test substance as supplied; 3) Test substance in FCA (50/50 v/v).
- Control group: Vehicle control for test substance, Positive control (hexyl cinnamic aldehyde (HCA)), Vehicle control for positive control.
- Site: Scapular region
- Frequency of applications: As noted above.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: One day, two weeks after topical induction.
- Exposure period: 24 hours
- Test groups: Test group and vehicle control group were exposed to 0.2 mL test substance and 0.2 mL test substance in Alembicol D (50% v/v).
- Control group: Positive control groups were exposed to HCA and HCA 50% in Alembicol D
- Site: Test substance or HCA as supplied was applied to an anterior site; test substance or HCA in Alembicol D was applied to the posterior site.
- Evaluation (hr after challenge): 24 and 48
Positive control substance(s):
yes
Remarks:
Hexyl Cinnamic Aldehyde
Positive control results:
One positive control animal was killed for humane reasons prior to challenge application. The surviving 9 animals showed evidence of dermal reactions compared to none in the controls. Therefore all surviving test animals gave positive responses.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 mL, material as supplied or 50% in Alembicol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0.
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded..
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 mL, material as supplied or 50% in Alembicol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0.
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 mL, material as supplied or 50% in Alembicol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded..
Key result
Reading:
other: positive
Group:
positive control
Dose level:
10% and 50%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: None
Remarks:
None
Key result
Reading:
other:
Group:
negative control
Dose level:
50:50 FCA and water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
None
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: challenge
Dose level:
Test group and vehicle control group were exposed to 0.2 mL test substance and 0.2 mL test substance in Alembicol D (50% v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of toxicity
Remarks on result:
no indication of skin sensitisation
Remarks:
No signs of sensitisation
Interpretation of results:
other:
Remarks:
EU-GHS criteria not met
Conclusions:
In this study TEGDB did not produce evidence of skin sensitization delayed contact hypersensitivity in any ofthe twenty test animals.
Evidence of skin sensitization was produced by hexyl cinnamic aldehyde (HCA) in all of the positive control test animals thus confirming the sensitivity of the method.
Executive summary:

A study was performed to assess the skin sensitization potential of the test substance TEGDB to guinea pigs. The study was conducted in accordance with OECD, EC and US EPA test guidelines, and in compliance with GLP.

The test substance was used as supplied for topical and intradermal injection induction exposures and as supplied and as a 50% (w/v) solution in Alembicol D for topical challenge exposure. Hexyl cinnamic aldehyde was used as positive control. Evidence of skin sensitization was seen in all animals treated with this substance, but no reactions were observed in the control group, confirming the sensitivity of the method. 

No evidence of toxicity or ill health were recorded for any animal exposed to the test substance. There were no dermal reactions seen in any of the test animals, therefore all these animals gave negative responses.

TEGDB did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the animals tested.

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

This substance is a reaction mass of diethylene glycol dibenzoate (DEGDB), dipropylene glycol dibenzoate (DPGDB) and triethylene glycol dibenzoate (TEGDB). No testing has been performed on the reaction mass itself but data are available for DEGDB, DPGDB and TEGDB. All studies on the components were performed according to international test guidelines and in compliance with GLP.Guinea pig maximization studies, according to Magnusson & Kligman were performed. Evidence of skin sensitization was seen in all animals treated by the positive control substance, hexyl cinnamic aldehyde, confirming the sensitivity of the method. Guinea pigs were treated with stock test substance for the intradermal injection (as 50:50 in FCA) and topical induction phases, and stock and 50% in Alembicol D for the topical challenge phase.

At the end of the challenge phase, no positive reactions were observed in the any of the animals treated with the test materials.

In conclusion, the results of the studies indicate that the components of the reaction mass are not classified for skin sensitisation; therefore the reaction mass itself is also not classified for skin sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

On the basis of the findings in the reported skin sensitisation studies, and according to the criteria laid down in EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the components of the reaction mass do not represent a concern for humans and therefore the reaction mass itself is also not classified for skin sensitization.