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Diss Factsheets

Administrative data

Description of key information

Read-across approach:

- GPMT: not sensitising (OECD406, GLP, K, rel.2)

- LLNA: not sensitising (OECD429, GLP, K, rel.1)

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Positive control results:
No data.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse skin reactions
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse skin reactions
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse skin reactions
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No advese skin reactions
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Bodyweight gains of guinea pigs in the test group betwee day 0 and day 24 were comparable to those in the control group over the same period.

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the read-across approach, the target substance aluminium chloride hydroxide sulphate do not induce any adverse skin reactions in the test group. Therefore, the substance is not classified as a sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, 20 female Dunkin-Hartley guinea pigs were exposed once intradermally (0.1%) and 2 times epicutaneously (50%) to the test article. Ten control animals were only exposed once epicutaneously (50%) during challenge. Positive skin reactions were evaluated according to a grading scale, and were used to calculate the sensitization rate. Body weights were measured before and after study.

No mortality was observed during the test. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. Chlorhydrol Ultrafine produced a 0 % (0/20) sensitisation rate and was considered to be a non-sensitiser to guinea pig skin. Body weight gain was comparable between the test and control group.

Under the conditions of this Guinea Pig Maximisation Test (OECD 406) and based on the read across approach, the target substance aluminium chloride hydroxide sulphate do not induce any adverse skin reactions in the test group (sensitization rate: 0%). Therefore, the substance is not classified as a sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Positive control results:
The six monthly reliability check with Hexylcinnamaldehyde, indicates that the Local Lymph Node Assay as performed at the laboratory is an appropriate model for testing for contact hypersensitivity. At 25 % Hexylcinnamaldehyde, DPM/group and SI/group were 740 and 3.2, respectively.
Parameter:
SI
Value:
0.9
Test group / Remarks:
10 % test item group
Parameter:
SI
Value:
1.6
Test group / Remarks:
25 % test item group
Key result
Parameter:
SI
Value:
0.5
Test group / Remarks:
50 % test item group
Parameter:
SI
Value:
1
Test group / Remarks:
vehicle control group
Parameter:
SI
Value:
3.2
Test group / Remarks:
positive control group
Parameter:
other: disintegrations per minute (DPM)
Value:
202
Test group / Remarks:
10 % test item group
Parameter:
other: disintegrations per minute (DPM)
Value:
378
Test group / Remarks:
25 % test item group
Key result
Parameter:
other: disintegrations per minute (DPM)
Value:
109
Test group / Remarks:
50 % test item group
Parameter:
other: disintegrations per minute (DPM)
Value:
231
Test group / Remarks:
vehicle control group
Parameter:
other: disintegrations per minute (DPM)
Value:
740
Test group / Remarks:
positive control group

Main study:

Skin reactions/irritation: No irritation of the ears was observed in the control animals, the animals treated at 10 % and 25 % and in three animals treated at 50 %. The slight irritation as seen in two animals treated at 50 % and the slight to well-defined irritation as displayed by the positive control animals was considered not to have a toxicologically significant effect on the activity of the nodes.

Macroscopy of the auricular lymph nodes and surrounding area:

All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size, except for one extremely large left node in one experimental animal treated at 10 %. Since this animal also showed abnormalities of the left eye (dull appearance), this animal was rejected from the study and the results were not used for interpretation. No macroscopic abnormalities of the area surrounding the nodes were noted in any of the animals.

Body weights:

Body weights and body weight gain of experimental animals remained in the same range as controls over the study period except for the slight body weight loss as shown by the rejected animal with the abnormality at the left eye.

Toxicity and mortality:

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

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the read-across approach, the target substance aluminium chloride hydroxide sulphate is not classified as a skin sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In a local lymph node assay performed according to OECD Guideline 429 and in compliance with GLP, groups of CBA/J mice (5 females/dose) were treated with Aluminium sulphate at concentrations of 10, 25 and 50 % on three consecutive days, by open application on the ear (25 µL/ear). Five vehicle control animals were treated with vehicle alone (1% aqueous L92) and five positive controls were treated with Hexylcinnamaldehyde (25 %). Three days after the last exposure, all animals were injected with 3H–methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group. Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary irritation study at 25 and 50 % using one female/dose. 

No mortality and no clinical signs were observed during the observation period. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. No irritation of the ears was observed in the control animals, the animals treated at 10 % and 25 % and in three animals treated at 50 %. The slight irritation was seen in two animals treated at 50 % and the slight to well-defined irritation as displayed by the positive control animals was considered not to have a toxicologically significant effect on the activity of the nodes. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size, except for one extremely large left node in one experimental animal treated at 10 %. Since this animal also showed abnormalities of the left eye (dull appearance), this animal was rejected from the study and the results were not used for interpretation. No macroscopic abnormalities of the area surrounding the nodes were noted. The median DPM values for the experimental groups treated with test substance concentrations 10, 25 and 50 % were 202, 378 and 109, respectively. The median DPM values for the vehicle and positive control groups were 231 and 740, respectively. The SI values calculated for the substance concentrations 10, 25 and 50 % were 0.9, 1.6 and 0.5, respectively. SI values calculated for vehicle and positive control groups were 1.0 and 3.2, respectively. The SI of the positive control (α- hexylcinnamaldehyde) was > 3; this experiment was therefore considered valid.

Under these test conditions and based on the read-across approach, the target substance aluminium chloride hydroxide sulphate is not classified as a skin sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

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

A read-across approach was used to assess skin sensitisation potential of aluminium chloride hydroxide sulphate.

Two key studies were identifed.

Guinea Pig Maximisation Test:

The first key study (Jones, 1986, Kr. 2) was conducted according to the OECD guideline No 406 and in compliance with GLP. In this study, 20 female Dunkin-Hartley guinea pigs were exposed once intradermally (0.1%) and 2 times epicutaneously (50%) to Chlorohydrol Ultrafine. Ten control animals were only exposed once epicutaneously (50%) during challenge. Positive skin reactions were evaluated according to a grading scale, and were used to calculate the sensitization rate. Body weights were measured before and after study.

 

No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. No effects were observed on body weight. Chlorhydrol Ultrafine produced a 0 % (0/20) sensitisation rate and was considered to be a non-sensitiser to guinea pig skin.

 

Local Lymph Nodes Assay:

The second key study (van Huygevoort, 2009, Kr. 1) was conducted with aluminium sulphate according to the OECD guideline No 429 and in compliance with GLP. Following a preliminary screening test, three groups were treated with Aluminium sulphate at concentrations of 10, 25 and 50 %. A further group of five animals was treated with Water with 1 % pluronic L92 alone.

 

The irritant potential of Aluminium sulphate was assessed in parallel by measurement of ear thickness on days 1 to 6.

The Stimulation Index values were 0.9, 1.6 and 0.5 for the concentrations 10, 25 and 50% respectively .

The SI values calculated for vehicle and positive control groups were 1.0 and 3.2, respectively. This experiment was therefore considered valid.

 

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. No irritation of the ears was observed in the control animals, the animals treated at 10 % and 25 % and in three animals treated at 50 %. The slight irritation was seen in two animals treated at 50 % and the slight to well-defined irritation as displayed by the positive control animals was considered not to have a toxicologically significant effect on the activity of the nodes. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

 

Moreover, a supporting study (Jensch, 1998, rel.2) performed on the source substance Dialuminum chloride pentahydroxide according to the OECD guideline 406 (GPMT) gave also a negative result.

Under the test conditions of these studies and based on the read-across approach, the target substance Aluminium chloride hydroxide sulphate is not classified as a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

 

Self classification:

-Skin sensitisation: based on the available data, no additional self-classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

 

-Respiratory sensitisation: No data was available for respiratory sensitisation. However, this substance is not a skin sensitizer, therefore according to Figure R.7.3 -2 of the Chapter R.7 (V 4.1 - October 2015) the chemical is not considered as a respiratory sensitizer.