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Administrative data

Description of key information

Groups of 2 rabbits each were applied with dose levels of 500, 1,000, 2,000, 4,000, or 8,000 mg/kg bw of Dechlorane Plus on the intact or abraded skin. No substance-related effect at all was seen in any of the 20 rabbits used.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
single administration
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Klimisch Rating 2, purity and physicochemical properties of the test substance not given, age of test organism not given.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
signs of systemic toxicity besides mortality not recorded
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sherman
Sex:
male/female
Details on test animals and environmental conditions:
No details reported
Route of administration:
oral: gavage
Vehicle:
other: water containing 0.5% tween 80
Details on oral exposure:
animals starved for 24 hours followed by single gavage administration
Doses:
1,500, 3,000, 6,000, 12,500, 25,000 mg/kg bodyweight
No. of animals per sex per dose:
3 males and 2 females per dose
Control animals:
no
Details on study design:
Administration followed by a 14 days postdose observation period, only mortality recorded, no recording of signs of systemic toxicity besides mortality
Statistics:
none
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 25 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: no toxic effect observed
Mortality:
none
Clinical signs:
none reported
Body weight:
not determined
Gross pathology:
not determined
Other findings:
none reported

Dose level     Dose level       Day - Mortality

ml/kg              mg/kg              1       2       3       4       5       6       7       8       9       10      11     12     13      14     total

3.0               1,500               0       0       0       0       0       0       0       0       0        0        0       0       0        0       0 

6.0                  3,000              0       0       0       0       0       0       0       0       0        0        0       0       0        0       0

12.0               6,000              0       0       0       0       0       0       0       0       0        0        0       0       0        0       0

25.0              12,500              0       0       0       0       0       0       0       0       0        0        0       0       0        0       0   

50.0              25,000              0       0       0       0       0       0       0       0       0        0        0       0       0        0       0    

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not toxic according to EU criteria, LD50 > 25000 kg/kg bw
Executive summary:

Groups of 3 male and 2 female rats were given Dechlorane Plus as suspension in aqueous methylcellulose once orally at dose levels of 1,500, 3,000, 6,000, 12,500, or 25,000 mg/kg bw by gavage and were observed for 14 days for mortality. No mortality occurred. The NOEL was determined at 25,000 mg/kg bw. Dechlorane Plus was nontoxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
25 000 mg/kg bw
Quality of whole database:
In two studies using high dose levels, no effect at all was observed. The quality is sufficient to demonstrate the nontoxicity of Dechlorane Plus.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Purity and physical chemical properties of test substance not given, age of animals not given, concentration in air not analytically verified.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Exposure for 4 hours to one concentration with 14 days postdosing observation period, one group of 5 males and 5 females, particle size distribution determined, mortality, bodyweights, and gross pathology recorded
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Charles River
Sex:
male/female
Details on test animals and environmental conditions:
No further details reported.
Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
clean air
Details on inhalation exposure:
Particle size distribution 56.8% at 1-5 µm, 10.2% at 6-10 µm, 14.8% at 11-25 µm, 18.2% at >25 µm, exposure for 4 hours, no further details reported.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
2.25 mg/l
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
4 hours exposure, 14 days postexposure observation time, mortality, bodyweight, and gross pathology were recorded. No further details reported.
Statistics:
none
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 2.25 mg/L air (nominal)
Based on:
act. ingr.
Exp. duration:
4 h
Remarks on result:
other: no mortality, no effects on bodyweights, no changes in gross pathology
Mortality:
none
Clinical signs:
none reported
Body weight:
no effects
Gross pathology:
no effects
Other findings:
no other findings
Interpretation of results:
GHS criteria not met
Conclusions:
Not toxic at a concentration of 2.25 mg/l in air as dust upon 4 hours of inhalation.
Executive summary:

Groups of 5 male and 5 female rats were exposed by inhalation to Dechlorane Plus 25 at a concentration of 2.25 mg/l as dust in air for 4 hours. No treatment-related effects were observed. The NOEL was determined at 2.25 mg/l. Dechlorane Plus 25 was not toxic by inhalation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
2 250 mg/m³
Quality of whole database:
Two studies are available, and no effects were observed at 2.25 mg/l in one study and at 300 mg/l in the other study. The quality is sufficient to demonstrate the nontoxicity of Dechlorane Plus.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Single administration, duration not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Purity and chemical physical properties of the test substance not mentione, strain, sex, and age of the test animals not mentioned, environmental contiditons and feeding not mentioned.
Qualifier:
according to
Guideline:
other: Federal Register 26(155):7336, 12 August 1961
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No details on environmental conditions reported
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Application to intact and abraded skin, no further details on dermal exposure reported
Duration of exposure:
Not reported
Doses:
500, 1,000, 2,000, 4,000, 8,000 mg/kg bodyweight
No. of animals per sex per dose:
2 rabbits with intact skin and 2 rabbits with abraded skin per dose level, sex not reported
Control animals:
no
Details on study design:
No further details reported
Statistics:
none
Key result
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 8 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: no effects observed up to the highest dose
Mortality:
none
Clinical signs:
none reported
Body weight:
not recorded
Gross pathology:
not recorded
Other findings:
no other findings observed

dose       No rabbits       Mortality       No rabbits       Mortality

mg/kg     skin intact                            skin abraded

500               2                     0                     2                     0

1,000            2                     0                     2                     0

2,000            2                     0                     2                     0

4,000            2                     0                     2                     0

8,000            2                     0                     2                     0

Interpretation of results:
GHS criteria not met
Conclusions:
Nontoxic according to EU criteria
Executive summary:

Two rabbits each were administered Dechlorane Plus once dermally on intact or abraded skin at dose levels of 500, 1,000, 2,000, 4,000, or 8,000 mg/kg bw for an unspecified period of time. No mortality was observed. The NOEL was determined at 8,000 mg/kg bw. Dechlorane Plus was not toxic upon dermal application.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
8 000 mg/kg bw
Quality of whole database:
As no effect was observed at a very high dose level, the quality appears sufficient to demonstrate the nontoxicity of Dechlorane Plus.

Additional information

Dechlorane Plus was essentially nontoxic upon single oral, dermal, or inhalative exposure.

Justification for selection of acute toxicity – oral endpoint

Higher dose levels and more animals per group used.

Justification for selection of acute toxicity – inhalation endpoint

The particle size distribution was determined.

Justification for selection of acute toxicity – dermal endpoint

No effects at a high dose levels, only one acute toxicity study with dermal application is available.

Justification for classification or non-classification

Dechlorane Plus was essentially nontoxic upon single oral, dermal, or inhalative exposure and thus is not subject to classification according to CLP (Regulation EC No 1272/2008).