Registration Dossier

Administrative data

Endpoint:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CHarles River UK
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: less than 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: 15/11/09 To: 02/12/09

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:

SCORING SYSTEM: as reported in OECD GL 405


TOOL USED TO ASSESS SCORE: ophtalmic examination lamp/fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: 24-72 hours (mean value)
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
other: 24-72 hours (mean value)
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
other: 24-72 hours (mean value)
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Redness, chemosis and discharge of the conjunctiva were observed in all the animals 1 hour after the exposure. Redness persisted in alll anumals. Irritation resolved wihtin 7 days for 1 animal and within 72 hours for the other 2. No iridial irritation or corneal opacity were observed.
Other effects:
no mortality or symptoms of systemic toxicity occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Only minimal irritation was observed. The irritation score did not meet the criteria for classification.