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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance to OECD GL

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1,3,3-pentachlorobutane
EC Number:
244-691-9
EC Name:
1,1,1,3,3-pentachlorobutane
Cas Number:
21981-33-9
Molecular formula:
C4H5Cl5
IUPAC Name:
1,1,1,3,3-pentachlorobutane
Details on test material:
- Name of test material (as cited in study report): 1,1,1,3,3-pentachlorobutane
- Molecular formula (if other than submission substance): same as submission substance
- Molecular weight (if other than submission substance): same as submission substance
- Smiles notation (if other than submission substance): same as submission substance
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: liquid
- Analytical purity: 90%
- Impurities (identity and concentrations):
- Purity test date: 09/09/99
- Lot/batch No.: 99350L08
- Expiration date of the lot/batch: 13/09/2000
- Stability under test conditions: stable
- Storage condition of test material: at room temeprature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: 3.5 kg
- Housing: individual housing
- Diet : standard diet approximately 100 g/day
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 30-70%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From:9/11/99 To:30/11/99

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
21 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm
- % coverage:
- Type of wrap if used: Metalline patch mounted on Micropore tape and secured with an elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned with water after the exposure period
- Time after start of exposure: 4 hours


SCORING SYSTEM: As reported in the OECD GL 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 hours (mean value)
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 hours (mean value)
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72 hours (mean value)
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 hours (mean value)
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 hours (mean value)
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72 hours (mean value)
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Well defined or severe edema and erythema were observed in all animals. Scaliness was observed in 1 animal after 7 and 14 days. reduced flessibility, fissuring and/or bald skin were observed in the other 2 rabbits between 72 hours and 14 days. Complete reversibility was observed within 21 days. No corrosion was observed.
Other effects:
Sticky remnants of the test substance were present immediately after the patch removal and ceaning of the treated skin. Dry remnants were present in all animals between 1 and 48 hours after treatment.

No mortality or signs of systemic toxicity were observed in the study.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results 1,1,1,3,3-pentachlorobutane is to be regarded as irritating for the skin.
Classification as Xi, R38 (irritating to skin) under 67/548/EEC and as Skin irritation Category 2 (H315: Causes skin irritation) is warranted.