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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1-trichloro-2-methyl-2-propanol hemihydrate
Cas Number:
6001-64-5
Molecular formula:
C4H7Cl3O H2O
IUPAC Name:
1,1,1-trichloro-2-methyl-2-propanol hemihydrate
Test material form:
solid: crystalline
Details on test material:
transparent and crystalline solid at ambient temperature

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: he EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis
Details on animal used as source of test system:
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Tissue Amount
1 25.8 mg
2 25.5 mg
3 24.7 mg
Duration of treatment / exposure:
1 hour
Duration of post-treatment incubation (if applicable):
23 hours 25 minutes
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean
Value:
3.8
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Designation

Chlorobutanol Hemihydrate

Positive Control

% Tissue viability (tissue 1)

4.1%

3.9%

% Tissue viability (tissue 2)

3.7%

4.3%

% Tissue viability (tissue 3)

3.6%

4.3%

% Tissue viability (mean)

3.8%

4.1%

± SD of mean tissue viability (%)

0.3%

0.2%

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test item Chlorobutanol Hemihydrate is considered as at least irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 3.8%. This value is below the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.
Executive summary:

One valid experiment was performed.

Three tissues of the human skin model EpiDermTMwere treated with Chlorobutanol Hemihydrate for 60 minutes.

The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).

DPBS-buffer was used as negative control and 5% SDS solution was used as positive control.

After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.2. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 4.1 % (required:<20%).

The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%). 

 

After the treatment with the test item, the mean value of relative tissue viability was reduced to 3.8 %. This value is below the threshold for skin irritation potential (50%). Test items that induce values below the threshold of 50% are considered at least irritant to skin. 

 

The OECD guideline 439 addresses the human health endpoint skin irritation and does not allow discrimination between skin irritation (category 2) and skin corrosion (category 1). For these purposes, further testing with other suitable test methods is required.

 

Therefore, Chlorobutanol Hemihydrate is considered at least irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.