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Diss Factsheets

Administrative data

Description of key information

Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583-35-4)

Significant differences between the test group and the vehicle-treated controls were found with the test material. The compound therefore has a skin sensitising (contact allergenic) potential in albino guinea pigs.

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:
supporting study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
according to guideline
Guideline:
other: Buehler (1965) and Ritz and Buehler (1980)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 332 to 480 g
- Housing: individually in wire mesh suspension cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least four days


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark


IN-LIFE DATES: From: 1989-05-18 To: 1989-06-24
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
Primary irritation: undiluted, 50, 25, 10, 5.0, 2.5, 1.0 and 0.5 % w/v in acetone
Induction: 50 % w/v in acetone
Day(s)/duration:
once a week for three weeks
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
Challenge: 1 % w/v in acetone
Day(s)/duration:
3 exposures over 3 weeks, evaluated after 24 and 48 hours
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS: conducted as the irritation phase with the purpose of determining the proper level of test material to be used in the Induction and Challenge phases.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: approx. 6-hr
- Test groups: Test material in acetone
- Control group: none
- Site: left shoulder
- Frequency of applications: once a week for three weeks
- Duration: untreated for 2 weeks before challenge
- Concentrations: 50% w/v in acetone


B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: 3 exposures over 3 weeks
- Exposure period: approx. 6-hr
- Test groups: test material
- Control group: test material
- Site: left rear
- Concentrations: 1% w/v in acetone
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:
10 naive controls at challenge
Positive control substance(s):
no
Positive control results:
not applicable
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 % w/v in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slightly patchy erythema (10/20)
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 % w/v in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
slightly patchy erythema (6/10)
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% w/v in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slightly patchy erythema (4/20)
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1% w/v in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
slightly patchy erythema (2/10)
Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of this study, the test material was not a sensitiser.
Executive summary:

The potential of the test material to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the Buehler method. A 50 % w/v formulation in acetone was used. Following primary challenge there were no grades of 1 produced in the test or control animals. The incidence of a slightly patchy erythema response in the test group (10 of 20) was compared to that of the naive control group (6 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitisation had not been induced.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material.
Justification for type of information:
Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583-35-4), see attached justification.
Reason / purpose for cross-reference:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% w/v in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slightly patchy erythema (10/20)
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 % w/v in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
slightly patchy erythema (6/10)
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 % w/v in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slightly patchy erythema (4/20)
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 % w/v in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
slightly patchy erythema (2/10)
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583-35-4), see attached justification.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 mL at 0.1 %
No. with + reactions:
9
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 mL at 0.1 %
No. with + reactions:
20
Total no. in group:
20
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Restriction: Composition/purity of the test substance not reported.
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
according to guideline
Guideline:
other: Maurer et al, 1975
Deviations:
not specified
GLP compliance:
no
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
The study was conducted prior to the LLNA becoming the preferred method.
Species:
guinea pig
Strain:
other: Pirbright white
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 400 to 450 g
- Housing: individually in Macrolon cages, type 3
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity 55 ± 5%
- Photoperiod (hrs dark / hrs light): 14 hours light / 10 hour dark

Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 mL (0.1 %)
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 mL
No. of animals per dose:
20
Details on study design:
During the first week volumes of 0.1 mL of the test material (0.1%) in saline without adjuvant were injected intradermally on Monday at two sites (flank and back), and on Wednesday and Friday at each one site on the back. Twenty-one hours after administration, the animals were chemically depilated with Butoquick and three hours later the skin reaction was assessed under artificial lighting. The two largest diameters of the erythematous reaction in vertical alignment were measured (mm) and the skin-fold thickness was determined with a skin-fold gauge (mm). The individual "reaction volume" (µL) was calculated from these values for each reaction from each animal.

During the second and third week of induction the substance was mixed with adjuvant (Bacto Adjuvant, complete Freund's Adjuvant) in a 1:1 ratio. A total of 6 sensitising doses of 0.1 mL were injected intracutaneously into the skin of the neck on Monday, Wednesday and Friday. The reactions were not evaluated on these occasions. The test for skin sensitisation was performed two weeks after the last sensitising treatment with the adjuvant mixture. For the test 0.1 mL of the same substance formulation, as employed during the first testing week, was injected intradermally on the previously untreated flank. Twenty-four hours later the reaction site was evaluated in the same manner as during the first testing week.

A group of 20 guinea pigs treated in the same manner with the control vehicle alone served as negative and another group treated with dinitrochlorobenzene as positive control.

For each animal the mean value plus one standard deviation was calculated for the reaction volumes of the 4 intracutaneous injections from the first testing week. Ten days after the intracutaneous challenge injection sub irritant doses at the test material were applied epicutaneously under occlusive dressing which were left in place for 24 hours.
Challenge controls:
Twenty guinea pigs were treated in the same way with the control vehicle alone served as the negative controls.
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene
Positive control results:
- Significant skin sensitisation
- Rate of positive reactors: 20/20 animals
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
9
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1%
No. with + reactions:
20
Total no. in group:
20

A positive reaction was observed.  

Erythema scores (Draize scores), 24  hours after removal of dressing, by sex:

Males: 4/10 had a score of 1

Females: 7/10 had a score of 1

Interpretation of results:
other: EU Category 1 (H317: May cause an allergic skin reaction).
Conclusions:
Significant differences between the test group and the vehicle-treated controls were found with the test material. The compound therefore has a skin sensitising (contact allergenic) potential in albino guinea pigs.
Executive summary:

The optimisation test was used, an intracutaneous sensitisation procedure, to determine the sensitisation potential of the test material. The test was performed on groups of 10 male and 10 female guinea pigs. Dinitrochlorobenazene was used as the positive control. Skin sensitisation was defined to occur for the challenge reaction whenever the reaction volume exceeded the mean value plus one SD of the 4 pre-sensitisation reponses.

Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were found with the test material. The compound therefore has a skin sensitising (contact allergenic) potential in albino guinea pigs. Dinitrochlorobenzene caused significant skin sensitisation potential in albino guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583-35-4)

- Sachsse (1975), key study

The optimisation test was used, an intracutaneous sensitisation procedure, to determine the sensitisation potential of the test material. The test was performed on groups of 10 male and 10 female guinea pigs. Dinitrochlorobenazene was used as the positive control. Skin sensitisation was defined to occur for the challenge reaction whenever the reaction volume exceeded the mean value plus one SD of the 4 pre-sensitisation reponses.

Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were found with the test material. The compound therefore has a skin sensitising (contact allergenic) potential in albino guinea pigs. Dinitrochlorobenzene caused significant skin sensitisation potential in albino guinea pigs.

- Kreuzmann (1989), supporting study

The potential of the test material to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the Buehler method. A 50 % w/v formulation in acetone was used. Following primary challenge there were no grades of 1 produced in the test or control animals. The incidence of a slightly patchy erythema response in the test group (10 of 20) was compared to that of the naive control group (6 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitisation had not been induced.

Since the optimisation testing protocol provides a more-sensitive measure of sensitisation than the Buehler method, Sachsse was selected as the key study.


Dermal sensitisation in guinea pigs from the key study: sensitiser

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance requires classification with respect to skin sensitisation Category 1 (H317: May cause an allergic skin reaction).