Registration Dossier

Administrative data

Description of key information

No in vivo animal or in vitro studies are available on the registered substance. However, information that addresses the skin sensitization endpoint are available from the other ADPODS category members (refer to full ADPODS category justification document) and from clinical study with DOWFAX 2A1.

In vitro studies are available with the close category member DOWFAX 3B2 (one tested as formulation product in the KeratinoSens assay and one, DPRA, tested as the active only). Three Klimisch 1 studies and one K2 in vivo Guinea pig studies on two ADPODS category members (shortest and longest alkyl chain derivatives) are available for the skin sensitization endpoint. In addition, human repeat insult patch test assay is available for the registered substance DOWFAX 2A1. All these ADPODS category members differ only by the number of carbons within the alkyl side chain (refer to full ADPODS category justification document) that will not have an impact on skin sensitization properties of these members. In addition, DPRA assay study outcome with the closest category member of similar alkyl side chain length to DOWFAX 2A1 supports conclusions of negative dermal sensitization potential for this category member. In vitro cell-based assays may not be appropriate for these substances with strong surfactant properties. The overall weight of evidence evaluation indicates that the registered substance is not a dermal sensitizer. (Also refer to full read-across ADPODS category justification document).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
pre-existing data.
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 406 and EU Method B.6 (Skin Sensitisation) and in accordance with the Principles of Good Laboratory Practice (GLP)
Justification for type of information:
Please see category justification document.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was carried out Pre-LLNA and pre- in vitro test guidelines, and was based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, •Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens". Also LLNA testing is not applicable to surfactants as it produces false positives.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Chrales River, Germany
- Age at study initiation: approximately 5 weeks old (nulliparous and non-pregnant)
- Weight at study initiation: < 500 g
- Housing: group housed - 5 animals/cage
- Diet : ad libitum access to standard guinea pig, including ascorbic acid pellet
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Preliminary study - 50%, 20%, 10%, 5%, 2% and 1Z%
Main study - 1% concentration for the intradermal induction and a 50% concentration for the epidermal induction exposure
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Preliminary study - 50%, 20%, 10%, 5%, 2% and 1Z%
Main study - 1% concentration for the intradermal induction and a 50% concentration for the epidermal induction exposure
No. of animals per dose:
Preliminary study - 4 animals
manin study - 10 experimental + 5 control
Details on study design:
RANGE FINDING TESTS:
Induction (intradermal and epidermal) - The highest possible concentration that produced moderate irritation (the intradermal reactions may include slight necrosis « 3 mm in diameter)).
Challenge: - The maximum non-irritant concentration. The test substance concentrations used were from the series: Undiluted (if a liquid), 50%, 20%, 10%, 5%, 2%, 1% and, if needed, further lower concentrations using the same steps. The test system, procedures and techniques were identical to those used during the main study, unless otherwise specified. The animals were selected from stock and were between 5 and 9 weeks old, and as a consequence the body weights could exceed 500 grams. Body weights were determined prior to treatment.
Intradermal injections: - Initially, a series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 ml/site) in the clipped scapular region. The resulting dermal reactions were assessed 24 and 48 hours after treatment. Based on the results in the initially treated animals, two additional animals were treated in a similar manner with four lower concentrations at a later stage.
Epidermal application: - A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape", which were held in place with Micropore tape" and subsequently Coban elastic bandage". The initially used animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The resulting dermal reactions were assessed for irritation 24 and 48 hours after exposure.

MAIN STUDY
INDUCTION - Experimental animals
Day 1 The scapular region was clipped and three pairs of intradermal injections (0.1 ml/site) were made in this area as follows:
A) A 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco. Detroit, U.S.A.) with water for injection (Fresenius AG, Bad Homburg, Germany).
B) The test substance at a 1% concentration.
C) A 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant .
Note: One of each pair was on each side of the midline and from cranial A) to caudal C).

Day 3 The dermal reactions caused by the intradermal injections were assessed for irritation.

Day 8 The scapular area between the injection sites was clipped and subsequently rubbed with 10% sodium-dodecyl-sulfate (50S, Boom, Meppel, The Netherlands) in vaseline using a spatula. This concentration of SDS provokes a mild inflammatory reaction.

Day 9 The 10% SDS treated area between the injection sites was treated with 0.5 ml of a 50% test substance concentration using a Metalline patch (2x3 cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage. The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance and the dermal reactions caused by the epidermal exposure were assessed for irritation.

INDUCTION - Control animals
The control animals were treated as described for the experimental animals, except that, instead of the test substance, the vehicle was administered.

CHALLENGE - All animals
Day 21 One flank of all animals was clipped and treated by epidermal application of a 50% test sUbstance concentration and the vehicle (0.5 ml each), using Metalline patches (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage. The dressing was removed after 24 hours exposure and the skin cleaned of residual test sUbstance and vehicle. The treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing.

Observations
Mortality/viability - twice daily
Toxicity - at least once daily
Body weights - prior to start and at termination of the study
Irritation - Skin reactions were graded according to the recommended scoring system
After the end of the study all animals were euthanased by asphyxiation using an oxygen/carbon dioxide procedure
Challenge controls:
not applicable
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamic aldehyde technical, 85%
Positive control results:
The results of a reliability test performed not more than 6 months previously in response to the 10% and 5% test substance concentration in the challeng phase were considered indicative of sensitisation, based on the absence 0 any response in the control animals. These results lead to a sensitisation rate of 100% to both the 10% and 5% concentrations.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5% alpha-hexylcinnamic aldehyde
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5% alpha-hexylcinnamic aldehyde
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10% alpha-hexylcinnamic aldehyde
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10% alpha-hexylcinnamic aldehyde
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation

Preliminary study:

No signs of irritation were observed to the highest test substance concentration tested in the preliminary irritation study. Therefore, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction. A 50% test substance concentration was selected for the challenge phase. The test substance concentrations selected for the Main Study were a 1% concentration for the intradermal induction and a 50% concentration for the epidermal induction exposure.

Main study:

Induction phase - The reactions noted in the experimental and control animals after the epidermal induction exposure were considered to be enhanced by the SDS treatment.

Challenge phase - No skin reactions were evident after the challenge exposure in the experimental and control animals.

Toxicity/Mortality - No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.

Body Weights - Body weights and body weight gain of experimental animals remained in the same range as controls over the study period

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No evidence was obtained that DOWFAX* DRY HYDROTROPE POWDER had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC) and as per Guideline to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, DOWFAX* DRY HYDROTROPE POWDER does not have to be classified.
Executive summary:

The study with surfactant category member was carried out according to the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens". Test substance concentrations selected for the Main study were based on the results of a preliminary study. In the Main study, ten experimental animals were intradermally injected with a 1% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with the vehicle (Water) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC) , DOWFAX* DRY HYDROTROPE POWDER does not have to be classified for sensitisation by skin contact.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study
Justification for type of information:
Please see category justification document.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Remarks:
Not specified in report.
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Remarks:
Not specified in report.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was carried out Pre-LLNA and pre- in vitro test guidelines, and was based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, •Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens". Also LLNA testing is not applicable to surfactants as it produces false positives.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Specification
Thirty-two female, albino Dunkin-Hartley guinea pigs were supplied by David Hall Limited, Burton-on-Trent, Staffordshire, U.K. At the start of the main study the animals weighed 331 - 434g, and were approximately eight to twelve weeks old. After a minimum acclimatisation period of five days, each animal was selected at random and given a number unique within the study which was written both on a small area of cl ipped rump using a black indelible marker-pen, and on the cage card.

Husbandry
The animals were housed in groups of up to three in solid-floor polypropylene cages furnished with softwood shavings. Free access to mains 'tap water and food (Guinea Pig FD1 Diet, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study. The animal room was maintained at a temperature of 18 - 24°C and relative humidity of 47 - 65%. On three occasions the temperature was outside the lower limit specified in the protocol (19°C). This did not affect the.purpose or integrity of the study. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
Topical Induction : 75% (w/w) in distilled water
Topical Challenge : 75% (w/w) in distilled water
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
Topical Induction : 75% (w/w) in distilled water
Topical Challenge : 75% (w/w) in distilled water
No. of animals per dose:
20/test and 10/control
Details on study design:
The sensitising properties of the test material were assessed using the procedure of Buehler E.V. Toxic01 . Appl . Pharmacol (1964) 6: 341 and Arch.
Dermatol (1965) 91: 171-177.

Selection of Concentrations for Main Study (Siqhting Tests)
The concentrations of test material for the topical induction and topical challenge stages of the main study were determined by a 'sighting test' in which a group of guinea pigs were treated with various concentrations of the test material. The procedures were as follows:

a) Selection of Concentration for Topical Induction and Topical Challenge
Two previously untreated guinea pigs were treated with 0.5 ml of four concentrations of the test material in distilled water (75%, 50%, 25% and 10% w/w) . The highest concentration of the test material which did not produce excessive irritation, 24 or 48 hours after a 6-hour occlusive dermal exposure, was selected for the topical induction stage of the main study. This sighting test was also used to select the concentration for the topical challenge stage of the main study.

Main Study
A total of thirty guinea pigs were used for the study: twenty test and ten control animals.

The bodyweight of each animal was recorded at the start and end of the study.

Two main procedures were involved in the Buehler study; a) an induction of a response and b) a challenge of that response.

a) Induction
Induction of the Test Animals: The hair was removed from an area on the left flank of each animal with veterinary clippers. A topical application (0.5 ml) of the test material at a concentration of 75% w/w in distilled water was applied on absorbent lint (approximate size 15 mm x 35 mm) which was held in place under a strip of surgical adhesive tape (BLENDERM: approximate size 50 mm x 60 mm) and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 70 mm) wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 6 hours. The induction procedure was repeated on the same site on days 7 and 14 for a total of three 6-hour exposures.

Approximately 24 hours after each induction application (days 1, 8 and 15) any erythematous reactions were quantified using a four
point scale.

Induction of the Control Animals: The topical appl ications followed the same procedure as for the test animals except that the vehicle alone was appl ied.

b) Challenge
Shortly before treatment on day 28, an area approximately 50 mm x 70 mm on the right flank of each animal, was clipped free of hair with veterinary clippers. A quantity of 0.5 ml of the test material at a concentration of 75% w/w in distilled water was applied to the shorn right flank of each animal on absorbent lint (approximate size 15 mm x 30 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 40 mm x 50 mm) .

The patches were occluded with an overlapping length of aluminium foil and secured by a strip of adhesive bandage (ELASTOPLAST: approximate
size 250 mm x 70 mm) wound in a double layer around the torso of each animal.

After six hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The position of the treatment sites were identified by using a black indelible marker-pen. Approximately 24 and 48 hours after dressing removal, any erythematous reactions were quantified using the four-point scale shown below:
Scale : 0 - no reaction
I - scattered mild redness
2 - moderate and diffuse redness
3 - intense redness and swelling

CLASSIFICATION OF SENSITISATION RESPONSE
A comparison of the intensities and durations of reactions at the test material challenge sites in both test and control animals permits identification of sensitisation reactions.

If the test material at the maximum non-irritant concentration produces reactions in test animals at the 24 or 48-hour reading, these reactions
are attributed to contact sensitisation. This pre-supposes that no similar reactions are observed at the test material challenge sites of any of the
control animals. If irritation is observed in the control animals, only reactions in the test animals that exceed the most severe reaction seen in the control animals are attributed to contact sensitisation. The results are expressed in terms of incidence and severity of responses, i .e. Severity score: sum of skin responses at each observation divided by the number of animals in the group and Incidence score: total number of animals showing sensitisation responses divided by number of animals in group.

The incidence of sensitisation responses can be classified as follows :
% of animals Classification of
sensitised sensitisation potential
0 non-sensitiser
> 0 - 8 weak sensitiser
>8 - 28 mild sensitiser
> 28 - 64 moderate sensitiser
> 64 - 80 strong sensitiser
> 80 - 100 extreme sensitiser

The data obtained may be used to classify the test material under the Council Directive 67/548/EEC, as amended by Commission according to
Directive 83/467/EEC, on the classification, packaging and labelling of dangerous substances. These classification criteria are also in the U.K.
Approved Code o f Practice " Classification and Labelling of Substances Dangerous for Supply".

A response in at least 15% of the animals is considered positive and the risk phrase R 43 "MAY CAUSE SENSITISATION BY SKIN CONTACT" is required.
Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
2,4-Dinitrochlorobenzene (DNCB)
Concentration:
Not applicable
No. of animals per dose:
Not applicable
Details on study design:
Not applicable
Statistics:
None
Positive control results:
The known contact sensitiser, 2,4-DINITROCHLOROBENZENE (DNCB) produced a 100% (10/10) sensitisation rate. This was considered to be a satisfactory sensitisation response for this material under the conditions of the test.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75% (w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75% (w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 (distilled water)
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
One control animal was found dead on day 19.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 (distilled water). No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: One control animal was found dead on day 19..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 (distilled water)
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
One control animal was found dead on day 19.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 (distilled water). No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: One control animal was found dead on day 19..
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Main Study

a) Skin Reactions Observed After Topical Induction

No adverse reactions were elicited by the test material during induction.

b) Skin Reactions Observed After Topical Challense

The results are summarised as follows :

TEST: Both readings at 24 and 48 hours resulted in an incidence of 0/20

CONTROL: Both readings at 24 and 48 hours resulted in an incidence of 0/9

One control animal was found dead on day 19. This did not affect the purpose or integrity of the study.

No adverse reactions were noted at the test material sites of the test or control animals at the 24 and 48-hour observations.

Body weight:

Body weight gains of guinea pigs in the test group, between day 0 and day 30, were comparable to those observed in the control group animals over the same period.

Interpretation of results:
GHS criteria not met
Conclusions:
DOWFAX 8390, therefore, produced a 0% (0/20) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin.

DOWFAX 8390 was also classified as a non-sensitiser according to EEC labelling regulations. No risk phrase is required.
Executive summary:

The concentrations of the test material for the main study were based on preliminary topical studies. Twenty treated and 10 control Dunkin-Hartley guinea pigs were used for the main study. Induction consisted of 3 topical applications (0.5 ml) of a 75% w/w concentration of the test material in distilled water (or distilled water alone for the controls) on days 0, 7 and 14. The 6-hour applications were on the same site under an occlusive dressing; the test sites were evaluated for any irritation response 24 hours after each induction. Challenge on day 28 consisted of a single, 6-hour, topical application (0.5 ml) of the test material at a concentration of 75% w/w in distilled water under occlusive dressing. Observations for any dermal reaction were made approximately 24 and 48 hours after removal of the patches.

Induction with the test material did not produce any adverse reaction. Challenge with the test material did not result in a sensitization reaction in any of the treated animals. Thus, the test material was a non-sensitizer to the skin of guinea pigs.

The results of this study indicate that DOWFAX 8390 Surfactant does not require a label for skin sensitization according to the criteria of the commission of the

European communities (Annex VI of Council Directive 67/548/EEC ).

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

There are no animal data available on the REACH substance itself; however, studies are available for two other ADPODS category members (refer to full ADPODS category justification document). The chemical differences between the analogue and the REACH substance (difference in side-chain chain length with the REACH substance having intermediate chain length between two source category members) would not be considered likely to influence sensitising potential. All key studies with guinea pigs showed negative potential for skin sensitization; this conclusion is supported by the outcome of DPRA assay with another category member. Therefore, the REACH substance would have low skin sensitising potential, and would not be classified according to GHS criteria. This statement is supported by the Shelanski and Shelanski human repeated insult patch test study performed using DOWFAX 2A1 in which there was no evidence of sensitising potential in 50 human subjects. Overall, DOWFAX 2A1 is not considered to be a human skin sensitiser.


Short description of key information:
Four K1 Studies (Guinea pig) on two structural analogues are available from the other ADPODS category members. In vitro investigations were performed on another category member. One human study is available on the REACH registered substance. All studies indicate that DOWFAX 2A1 is not a human skin sensitiser.

Justification for selection of skin sensitisation endpoint:
GLP guideline study for the shortest ADPODS category member.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data are avaliable for this endpoint. However due to the lack of sensitising capability via the dermal route (based on read across) it is unlikely that this substance would induce respiratory sensitisation following inhalation. Also, the probability of inhaling a significant amount is limited by the low vapour pressure.      

Justification for classification or non-classification

No classification for skin sensitising potential is required