Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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:
other company data
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
other: JMAFF guidance (2000), including the most recent revisions
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar strain Crl:WI (Han)
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 5x7 cm on the back of the animal was clipped.
- % coverage: approx. 10% of the total body surface, i.e. approx. 25cm2 for males and 18 cm2 for females



Duration of exposure:
Single dosage, on Day 1.
Doses:
2000 mg/kg (10 mL/kg) body weight.
No. of animals per sex per dose:
No.1 of animals is male
No.2 of animals is male
No.3 of animals is male
No.4 of animals is male
No.5 of animals is male
No.6 of animals is female
No.7 of animals is female
No.8 of animals is female
No.9 of animals is female
No.10 of animals is female

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
Lethargy, hunched posture, uncoordinated movements, quick breathing labored respiration, piloerection chromodacryorrhoea, ptosis and/or hypothermia were shown by all animals between Days 1 and 3, and for one male hunched posture was also noted on Day 11.
The treated skin area of all animals showed scales and/or scabs between Days 4 and 15, and showed brown staining between Days 2 and 15. Due to brown-red discolouration of the treated skin on Day 2, no scoring of the treated skin area was possible on that observation day.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefor considered not indicative of toxicity.
Other findings:
No abnormalities were found at macroscopic post mortem examination of the animals.

Any other information on results incl. tables

TABLE 1 MORTALITY DATA
TEST DATE 1 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
HOURS AFTER TREATMENT 0 2 4                            
MALES 2000 MG/KG ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­
FEMALES 2000 MG/KG ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 value of Everzol Orange ED-G Crude in Wistar rats was established to exceed 2000 ma/kg body weight.
Executive summary:

Everzol Orange ED-G Crude was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred.

Lethargy, hunched posture, uncoordinated movements, quick breathing, labored respiration, piloerection, chromodacryorrhoea, ptosis and/or hypothermia were shown by all animals between Days 1 and 3, and for one male hunched posture was also noted on Day 11.

The treated skin area of all animals showed scales and/or scabs between Days 4 and 15, and showed brown staining between Days 2 and 15. The treated skin area of all animals showed scales and/or scabs between Days 4 and 15, and showed brown staining between Days 2 and 15. Due to brown-red discolouration of the treated skin on Day 2, no scoring of the treated skin area was possible on that observation day.

The body weight gain during the observation period was within the range expected for rats used in this type of study.
No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD5O value of Everzol Orange ED-G Crude in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results, Everzol Orange ED-G Crude does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the: - Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007), - Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.