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Administrative data

Description of key information

The substance 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 (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
Intradermal skin sensitising study. Guinea pigs injected into dermis with test substance or positive/negative control substance every 48 hours for 10 applications. Challenged at 2 weeks after final injection with injectionof test material at a virgin site. Scores for erythema and edema at 24 and 48 hours post challenge to assess sensitising response.
GLP compliance:
not specified
Type of study:
intracutaneous test
Justification for non-LLNA method:
Existing study conducted in 1982.
Specific details on test material used for the study:
- AEPD Lot No.: NPP-41344
- 2-Amino-2-ethyl-1,3-propanediol: 85.34 wt%
- Methanol: 1.48 wt%
- Monomethyl amino butanol: 10.92 wt%
- Water: 1.89 wt%
- pH at 100%: 11.78
- pH 1% solution: 11.18
Species:
guinea pig
Strain:
Hartley
Sex:
male
Route:
intradermal
Vehicle:
water
Concentration / amount:
first 5 induction injections with a 1% aqueous solutionof AEPD, remaining 5 injections with a 0.05% aqueous solution of AEPD.
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
intradermal
Vehicle:
water
Concentration / amount:
Challenge injection with 0.05 and 0.01% injections (at different virgin sites)
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
The intradermal sensitisation study with AEPD (P-1050) was conducted in male guinea pigs according to Landsteiner and Jacobs procedure (Landsteiner, K., and J. Jacobs. "Studies on Sensitization of Animals with Simple Chemical Compounds." J. Exp. Med. -61: 643-656, 1935). Forty male guinea pigs weighing 250 to 300 g were divided into four groups of 10 each. The animals' backs and flanks were shaved free of hair. Group XIV was intradermally injected with 0.05 ml of 1% solution of P-1050 in saline. Group V (positive control) was similarly injected with 0.05 ml of 0.3% dinitrochlorobenzene (DNCB) solution (solubilized in minimum volume of alcohol and made to volume with saline). Groups XVI and XVII (negative controls) were injected with 0.05 ml of saline. After 24 hours and 48 hours the injected sites scored for erythema edema, according to Draize. At 48 hours, the intradermal injection procedure was repeated for each group with 0.1 ml of each solution two or three times a week until a total of 10 injections have been made. After the last injection, the animals were allowed to rest for two weeks. On the first day of the third week (or the 35th day after the first injection), the animals in each group were challenged intradennally with 0.1 m l of solution at a virgin site. Group XIV and Group XVII animals were challenged with P-1050 solution (0.05 and 0.01%). Groups V and XVI animals were challenged with 0.03% DNCB solution. At the end of 24 h, the injected sites were depilated. Three hours after the removal of the hair , the injected sites were scored for inflammatory skin reactions (erythema and edema). The sites were re-scored at 48 hours (24 hours after the first scoring).
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene (DNCB) 0.3%
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction with saline; challenge with 0.01% solution of test substance
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction with 0.9% saline; challenge with 0.05% solution of test substance
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: necrosis
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction with 0.9% saline; challenge with 0.03% solution of DNCB
No. with + reactions:
2
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction with 0.9% saline; challenge with 0.03% solution of DNCB
No. with + reactions:
2
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction with test substance; challenge with 0.01% solution of test substance
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction with test substance; challenge with 0.01% solution of test substance
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction with test substance; challenge with 0.05% solution of test substance
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: necrosis
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction with test substance; challenge with 0.05% solution of test substance
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: necrosis
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Induction with 0.3% DNCB; challenge with 0.3% DNCB
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Induction with 0.3% DNCB: challenge with 0.3% DNCB
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

During the induction phase the guinea pigs in the test group showed some skin reactions with AEPD (P-1050). The first five injections were made with 1% solution and the last five injections were made with 0.05% solution. None of the negative control animals showed any skin reactions. The positive control animals showed mild to necrotic skin reactions during the entire induction period. At challenge with 0.05% of AEPD, all the animals in the treatment group and the negative control group showed skin reactions, but none of the animals in either group showed any skin reactions with 0.01% solution. The DNCB (0.03%) eluted positive skin reactions in the positive control group and in some animals in the negative control group.

Interpretation of results:
not sensitising
Conclusions:
Undiluted AEPD was found to be a non-sensitizer when tested in the guinea pig (intradermal application).
Executive summary:

An intradermal sensitization test was conducted by injecting an AEPD solution (P-1050) intradermally in male guinea pigs according to Landsteiner and Jacobs procedure (Landsteiner, K., and J. Jacobs. "Studies on Sensitization of Animals with Simple Chemical Compounds." J. Exp. Med. -61: 643-656, 1935). Forty male guinea pigs weighing 250 to 300 g were divided into four groups of 10 each. The animals' backs and flanks were shaved free of hair. Group XIV was intradermally injected with 0.05 ml of 1% solution of P-1050 in saline. Group V (positive control) was similarly injected with 0.05 ml of 0.3% dinitrochlorobenzene (DNCB) solution (solubilized in minimum volume of alcohol and made to volume with saline). Groups XVI and XVII (negative controls) were injected with 0.05 ml of saline. After 24 hours and 48 hours the injected sites scored for erythema edema, according to Draize. At 48 hours, the intradermal injection procedure was repeated for each group with 0.1 ml of each solution two or three times a week until a total of 10 injections have been made. After the last injectio n , the animals were allowed to rest for two weeks. On the first day of the third week (or the 35th day after the first injection), the animals in each group were challenged intradennally with 0.1 m l of solution at a virgin site. Group XIV and Group XVII animals were challenged with P-1050 solution (0.05 and 0.01%). Groups V and XVI animals were challenged with 0.03% DNCB solution. At the end of 24 h, the injected sites were depilated. Three hours after the removal of the hair , the injected sites were scored for inflammatory skin reactions (erythema and edema). The sites were re-scored at 48 hours (24 hours after the first scoring).

During the induction phase the guinea pigs i n Group XIV showed some skin reactions with P-1050. The first five injections were made w i t h 1% solution and the last five injections were made with 0.05% solution. None of the animals in Groups XVI and XVII (negative controls) showed any skin reactions. The animals in Group V (positive control ) showed mild to necrotic skin reactions during the entire induction period. At challenge with 0.05% of P-1050, all the animals i n Group IV (treatment) and Group XVII (negative control) showed skin reactions, but none of the animals in either group showed any skin reactions with 0.01% solution. The DNCB (0.03%) eluted positive skin reactions in Group V (positive control group) and in some animals in Group XVI (negative control group).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Exiisting study conducted in 1982.
Specific details on test material used for the study:
- AEPD Lot No. 6G28DF18
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
Animals purchased at least 1 week prior to study and allowed to acclimatise. Healthy animals free of disease were selected for the study. 24 hours prior to test, animals examined for skin injury. Those with no injury were used in test. Animals were fed Purina Certified Rabbit Chow, ad libitum, certified free of contaminants by supplier. Animals were given tap water ad libitum. Water was tested to ensure levels of contaminants are equivalent to or less than recommended levels as per the primary drinking water regulations.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5 ml of a 0.5% aqueous solution of AEPD (first 5 applications); 0.5 ml of 0.05% aqueous solution of AEPD for the final 5 applications
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5 ml of a 0.5% aqueous solution of AEPD (first 5 applications); 0.5 ml of 0.05% aqueous solution of AEPD for the final 5 applications
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Details on study design:
Fifty male guinea pigs weighing 250-300 g were divided into five groups of 10 each. The animals ' backs and flanks were shaved free of hair. Group I (treatment group) was topically treated with 0.5 ml of 0.5% P-1050 aqueous solution and covered with a gauze under an occlusive patch. Group IV (positive control) was similarly treated with 0.5 ml of 0.3% dinitrochlorobenzene solution (DNCB, solubilized in a minimum volume of alcohol and made to volume with saline). Groups V, VII, and VIII (negative controls) were similarly treated with 0.5 ml of saline. After 24 hours exposure the patches were removed, the treated skin sites were cleaned and scored at 24 and 48 hours for erythema and edema according to Draize (Draize, J.H., "Appraisal of the Safety' of Chemicals in Foods, Drugs, and cosmetic. Assoc. of Food & Drug Officials of the United States, p. 48, 1957).

At 48 hours the topical application procedure was repeated with each group of animals two to three times a week until a total of 10 applications have been made. After the last application, the animals were allowed to rest for two weeks. On the first day of the third week (or the 36th day after the first application), the animals in each group were challenged as follows: Group I and Group V animals were challenged only with 1% and 0.05% of P-1050. Group IV and Group VIII animals were challenged with 0.3% DNCB solution solubilized in acetone instead of alcohol. Group VII (a negative control) was challenged with saline. After 24 h exposure, the patches were removed and the sites cleaned. At this time the challenge sites were depilated with "Nair" .Three hours after removal of the hair the challenge sites were scored for inflammatory skin reactions (erythema and edema). These sites are scored again at 48 h.
If the test material at challenge induces skin reactions in a large number of treatment group animals compared to the negative control, then the material is considered a sensitizer. The positive control group serves as an internal control for the test.
Challenge controls:
Negative control:
Saline treated (group VII) - saline treated throughout induction and challenged with saline
Irritation controls
Group V: treated with saline during induction, challenged with AEPD
Group VIII: treated with saline during induction, challenged with DNCB
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene (DNCB), 0.3% solution
Positive control results:
Positive control responded as expected witha clear sensitising response at 24 and 48 hours (8 out of 10 animals)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.05%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.05%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.05%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Irritation Control for AEPD
Dose level:
0.05%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Irritation Control for AEPD. Dose level: 0.05%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Irritation Control for AEPD
Dose level:
0.05%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Irritation Control for AEPD. Dose level: 0.05%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Irritation Control for AEPD
Dose level:
1%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Irritation Control for AEPD. Dose level: 1%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Irritation Control for AEPD
Dose level:
15%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Irritation Control for AEPD. Dose level: 15%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Irritation control for DNCB
Dose level:
0.3%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Irritation control for DNCB. Dose level: 0.3%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Irritation Control for DNCB
Dose level:
0.3%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Irritation Control for DNCB. Dose level: 0.3%. No with. + reactions: 5.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
saline
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
saline
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: saline. No with. + reactions: 0.0. Total no. in groups: 10.0.

Based on the results of the study, AEPD was irritating but not a sensitiser

Interpretation of results:
not sensitising
Conclusions:
AEPD was not sensitising, but a skin irritant (under the conditions of the study)
Executive summary:

A topical contact sensitization test was conducted in the m a l e guinea pigs according to Buehler's procedure (Buehler, E. V. "Delayed Contact Hypersensitivity in the Guinea Pig", It Arch. Dermat. -91: 171-175, 1965). Fifty male guinea pigs weighing 250-300 g were divided into five groups of 10 each. The animals ' backs and flanks were shaved free of hair. Group I (treatment group) was topically treated with 0.5 ml of 0.5% P-1050 aqueous solution an8 covered with a gauze under an occlusive patch. Group IV (positive control) was similarly treated with 0.5 rnl of 0.3% dinitrochlorcbenzene solution (DNCB, solubilizcd in a minimum volume of alcohol and made to volume with saline). Groups V, VfI, and VIII (negative controls) were similarly treated with 0.5 ml of saline. After 24 hours exposure the patches were removed, the treated skin sites were cleaned and scored at 24 and 48 hours for erythema and edema according to Draize. At 48 hours the topical application procedure was repeated with each group of animals two to three times a week until a total of 10 applications have been made.

In the initial test all the animals in the test and the negative controls developed skin rashes and the skin sensitization reactions could not be evaluated. The topical sensitization test was repeated with a new batch of animals. During the induction period (initial ten applications) some of the animals in Group 1 showed mild erythema when treated with 0.5% solution of P-1050, so the last five applications were made with 0.05% solution, The animals in Group IV (DNCB) showed mild skin reactions during the entire induction period, When challenged with 0.05% solution of P-1050, one animal in Group I (treatment) showed skin reactions at 48 h and six animals in Group V (negative control) showed skin reactions at 24 and 48 h. A rechallenge with 1% solution of P-1050, elicited skin reactions in more animals of the negative control group (eight) than of the treatment group (four). A t challenge with 0.3% DNCB solution, more of the animals in the positive control (Group IV) showed skin reactions than in the negative,control (Group VIII) group of animals at 24 and 48 hous. The negative control (Group VII) did not show any skin reactions with saline.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are two skin sensitisation studies available for 2-amino-2-ethyl-1,3-propanediol (AEPD). The first skin sensitisation study was conducted similar to OECD 406 (Parekh, 1982f). The Buehler´s procedure was used to test the sensitisation potential of AEPD via the topical route. During the induction period some of the guinea pigs in the test group showed mild erythema when treated with 0.5% solution of AEPD (first 5 applications), so the last 5 applications were made with 0.05% solution. The animals in the positive control group showed mild skin reactions during the entire induction period. When challenged with 0.05% of AEPD, one animal in the test group showed skin reactions at 48 h and 6 animals in the negative control group at 24 h as well as at 48 h. A solution of 1% of APED led to skin reactions in more animals of the negative control group (8 of 10) than of the test group (4 of 10) at the 24 h scoring. Also at the second reading, more animals of the negative control group (6/10) than of the test group (1/10) showed skin reactions. At challenge with 0.3% dinitrochlorobenzene (DNCB) solution, the positive control gave a valid response (8/10). Regarding that more animals of the negative control group of AEPD than of the test group showed skin reactions at challenge, it is not possible to judge the skin sensitisation potential of AEPD based on this study only.

In the skin sensitisation study of Parekh (1982f), no data on the pH value is given but from skin irritation studies, it is known that the pH value at 1% solution of AEPD was 11.18 and at 100% solution was 11.78. Therefore, due to the alkaline pH value, it is likely that the skin reactions observed in the present study could be attributed to irritation rather than sensitisation. In the second study, the skin sensitisation potential of AEPD was tested via the intradermal route (Parekh, 1982g). During the induction phase the guinea pigs in the test group showed some skin reactions with AEPD. The first 5 injections were made with 1% solution and the last 5 injections were made with 0.05% solution. None of the negative control animals showed any skin reactions. The positive control animals showed mild to necrotic skin reactions during the entire induction period. At challenge with 0.05% of AEPD, all animals in the test group (10/10) and in the negative control group (10/10) showed skin reactions, but none of the animals in either group showed skin reactions with 0.01% solution. The DNCB (0.03%) eluted skin reactions in the positive control group (10/10) and in some animals in the negative control group (2/10).

In conclusion, it is not possible to distinguish between a skin reaction caused by irritation and a skin reaction due to sensitisation. Therefore, the skin sensitisation potential of AEPD cannot be judged based on this study only.

There are no further animal data available on the skin sensitising potential of AEPD. However, there are reliable data for another member of the chemical category AEPD belongs to. The members of the category of 2-amino-1,3 propanediols are substances that share a common propane backbone with an amine group at 2-carbon position and primary alcohols at 1 and 3 positions. The following substances are thus members of the aminopropanediol category: 2-amino-2-ethyl-1,3-propanediol (AEPD, CAS No. 115-70-8), 2-amino-2-methyl-1,3-propane-diol (AMPD, CAS No. 115-69-5), 2-amino-1,3-propanediol (APD, CAS No. 534-03-2) and 2-amino-2-(hydroxymethyl)-1,3-propanediol (trometamol, CAS No. 77-86-1) The only structural difference between trometamol and AEPD is a replacement of a hydroxyl group with a methyl group. Further analogues differ in the length of the alkyl side-chain at position 2 so that the following sequence is obtained: from 0 carbon atoms (APD) through 1 (AMPD) to 2 (AEPD). There are no other functional groups present in these molecules.  

 

The modelling of potential metabolites via the OECD QSAR toolbox v.2.0 (2010) did not predict relevant metabolites of the category members. Based on the chemical structure of the parental compounds, no metabolism is expected. Therefore, it can be assumed that aminopropanediols will not show reactive properties under in vitro and in vivo test conditions. Furthermore, the results of the acute studies as well as the repeated dose studies indicate that the main cause of toxicity was the intrinsic alkalinity of the category members at the site of contact. By calculating the likelihood of interactions of the category members with skin proteins, no structural alerts were found. Therefore, no interactions of AEPD with skin proteins are expected and the read-across between the category members based on molecular similarity and absence of suspicious substructures is justified for the endpoint skin sensitisation. In conclusion, as APD, AEPD and AMPD were shown to form a robust chemical category, it is considered appropriate to read-across from AMPD (CAS 115 -69 -5) to AEPD.

To assess the skin sensitisation potential of AMPD, an in vitro assay method established by Natsch and Gfeller (2008) and modified by Jeong (2011) was used to determine the direct peptide reactivity, which is a key pathway leading to skin sensitisation. In this assay, a standard peptide consisting of one cysteine, two lysines and 4 other amino acids was incubated with the test substance in neutral pH condition to test for peptide depletion by chemical reactions (Jeong, 2011). After 24 h incubation, the test substance showed no peptide depletion similar to negative control, while the positive control depleted most of free peptides. Under the in vitro test conditions, there was no evidence that the test substance exhibits direct protein reactivity which would cause skin sensitisation.

Human data

In a human skin sensitisation study, dermatitis patients with present or past occupational exposure to water-based metalworking fluids (MWF) were patch tested with 13 – so far untested – MWF components including AEPD.

Only 1 of 160 patients reacted positively to AEPD. This patient did not react to other MWF components, in particular not to monoethanolamine and diethanolamine. Hence, no clinical relevance of the positive test reaction to AEPD could be found. However, not all the MWFs previously used by this patient could be identified. Therefore, previous occupational exposure and relevance could be regarded as possible. The lack of positive test reactions to AEPD may be due to its low sensitising potential or to a relatively low patch test concentration (1% aq.).

Taking into account all available data on skin sensitisation using a weight of evidence approach, AEPD is considered not to have a skin sensitisation potential.


Short description of key information:
Based on the available studies of AEPD and on read-across within the chemical category, it can be assumed that AEPD possesses no skin sensitisation potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data available.

Justification for classification or non-classification

Based on the weight of evidence of all available studies of AEPD and on read-across within the chemical category, the available data on skin sensitisation do not meet the criteria for classification to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and therefore it is expected that AEPD has no skin sensitisation potential.