Registration Dossier

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
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.