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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out according to US EPA Guidelines for acute dermal toxicity study (PB82-232984, August 1982) and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US EPA Toxic Substance Health Effects Test Guidelines (PB82-232984, 1982)
Principles of method if other than guideline:
US EPA Toxic Substance Health Effects Test Guidelines (PB82-232984, 1982) Acute dermal toxicity study
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Hydrogen peroxide, 35% w/w

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, Jamesburg, New Jersey
- Age at study initiation: Young adult
- Weight at study initiation: Males weighed between 2.1 to 2.45 kg, females weighed between 2.03 to 2.49 kg
- Fasting period before study: no data
- Housing: Individually in suspended, stainless steel, wire mash cages
- Diet (e.g. ad libitum): Purina Laboratory Rabbit Chow 5321 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 to 74 °F
- Humidity (%): 42 to 69 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A pretest was conducted. On the day prior to test material administration, the trunks of ten rabbits were clipped free of hair with an electric clipper. The clipped exposure sites extended from the scapulae to the pelvic girdle and encompassed approximately 20 % of the animal's body surface. Doses corresponding to a dosage level of 2000 mg/kg were individually calculated based on the body weight of each animal on the day of dosing. A 4x4 inch gauze pad was positioned on the intact test site and held in place with hypoallergenic tape. The test site was then occluded with impervious plastic sheeting for 24 hours. The test material was introduced under the gauze pad using a dosing needle and a syringe. Each animal was fitted with an everted plastic Elizabethan collar to prevent disturbance of the test site and possible ingestion of the test material. The animals were dosed approximately 3 hours after initiation of the light cycle.
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The animals were observed for mortality and clinical signs (local irritation excluded) at 0.5, 1, 2, 3, 4 and 6 hours on the day of dosing and twice daily thereafter for 13 days; on day 14 the animals were observed once. A description on the local irritation was recorded on day 1, 4, 7 and 14 of the study. Body weights were taken on the day of dosing and again on day 7 and 14. Rabbits were killed on day 14 of the study and submitted to gross necropsy.
Statistics:
No statistics were applied.

Results and discussion

Preliminary study:
none
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
Nasal discharge in one rabbit and lacrimation in another rabbit were observed on day 4 and 5 of the study, respectively.
Body weight:
Seven rabbits gained weight and three rabbits lost weight in the course of the study (see Table 1).
Gross pathology:
There were no gross internal lesions observed in any animal at necropsy.
Other findings:
Erythema, oedema and blanching of the test sites were observed in all rabbits 24 hours after administration. By day 4 of the study, all rabbits had necrosis which developed into eschar on day 7. At termination of the study, eschar and exfoliation were present in all rabbits.

Any other information on results incl. tables

Table 1: Mean body weights of test animals in the male and female dose groups

Gender

Mean body weights ± S.D. (kg)

Days after administration

0

7

14

Male

2.3 ± 0.15

2.12 ± 0.17

2.47 ± 0.21

Female

2.3 ± 0.2

1.93 ± 0.12

2.25 ± 0.28

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification for dermal toxicity is necessary for hydrogen peroxide (35%) according to Directive 2001/59/EC (adaptation of 67/548/EEC) or according to Regulation (EC) 1272/2008.
Executive summary:

The acute dermal toxicity of a 35 % aqueous solution of hydrogen peroxide was tested according to US EPA Guidelines (PB82 -232984, August 1982) and under GLP conditions. Male and female young adult New Zealand White rabbits received a single dose of 2000 mg/kg the test material under occlusion. Animals were prevented from manipulating the test site by the application of Elizabethan collars. Occlusion remained for 24 hours. After removal of the occlusion, animals were observed for 14 days. None of the animals died so that the dermal LD50 value was greater than 2000 mg/kg. All animals showed local skin irritation exhibiting erythema, oedema and blanching of the test sites after 24 hours and eschar and exfoliation at termination of the study. No gross internal lesions were found at necropsy at termination of the study.