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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1977 till June 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The authors tested the skin irritating potential of benzotrichloride on rabbits according to the method described by the Code of Federal Regulations, Title 16, Section 1500.41. GLP standards are not specified. Although only basic information is provided on materials and methods, the results are sufficiently described. Hence this study should be considered a klimisch 2b study, a guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ETAD methodology (Code of Federal Regulations, Title 16, Section 1500.41)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): benzotrichlorid
- Physical state: colourless, pungent liquid

No more data available

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, England
- Sex: male and female
- Weight at study initiation: 3 - 4 kg
- Housing: individually caged
- Diet: Rabbit food Z 222 (Fa. Höing, Verden/Aller) ad libitum
- Water: ad libitum


No more data available

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

No more data available
Duration of treatment / exposure:
24h
Observation period:
7d
Number of animals:
6
Details on study design:
SCORING SYSTEM:
Similar to the OECD scoring system described in OECD in OECD guideline 404

- Erythema and eschar formation (maximum value possible is 4):
No erythema ............................................................................................................................. 0
Very slight erythema (barely perceptible) ............................................................................ 1
Well-defined erythema ............................................................................................................ 2
Moderate to severe erythema ................................................................................................ 3
Severe erythema (beet redness) to slight eschar formations (injuries in depth) .......... 4

- Edema formation (maximum value possible is 4):
No edema ....................................................................................................................................................... 0
Very slight edema (barely perceptible) ...................................................................................................... 1
Slight edema (edges of area well defined by definite raising) ............................................................... 2
Moderate edema (raised approximately 1 millimeter) ............................................................................ 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) ......... 4


No more data available

Results and discussion

In vivo

Results
Irritation parameter:
other: primary irritation score
Basis:
mean
Time point:
other: 24h combined with 72h
Score:
2.8
Max. score:
8
Reversibility:
not reversible
Remarks:
within 7 days
Irritant / corrosive response data:
Erythema and edema of the skin were observed in all animals.
Erythema (grades 1-2) and edema (grade 1) persisted until study termination at day 7 in 6 out of 6 and 5 out of 6 animals, respectively.

Any other information on results incl. tables

- Table: Overview of erythema and edema scores for six rabbits which were exposed to benzotrichlorid during 24h. Scores were noted at the end of the exposure (24h) and after 72h and 7 d (respectively 48h and 6 days after ending exposure)

Animal Symptoms Toxicological findings Primary irritation score
Intact skin abraded skin
24h 72h 7d 24h 72h 7d
1 Erythema 1 2 2 2 2 2 Sum of all erythema and edema values for 24h and 72h divided by 24
Edema 1 1 1 2 1 1
2 Erythema 2 2 2 2 2 2
Edema 2 1 1 2 1 1
3 Erythema 2 2 2 1 2 2
Edema 2 1 1 1 1 1
4 Erythema 1 1 1 1 1 1
Edema 1 1 1 1 1 1
5 Erythema 2 1 1 2 1 1
Edema 2 1 0 2 1 1
6 Erythema 1 1 1 1 1 1
Edema 1 1 1 2 1 1
Sum erythema and edema 18 15 19 15 2.8

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: ETAD (Federal Regulations, Title 16)
Conclusions:
The authors tested the skin irritation potential of benzotrichloride on rabbits according to the method described by the Code of Federal Regulations, Title 16, Section 1500.41. In the test conditions very slight to well-defined erythema and very slight to slight edema was observed at 24h (end of exposure) and 72h (48h after ending exposure) for both intact and abbrated skin. This resulted in a primary irritation score of 2.8 (maximum is 8). Furthermore after 7d the effects of exposure to benzotrichloride were not reversible. Thus, benzotrichloride is considered slightly irritating according to the Code of Federal Regulation.
Executive summary:

The authors tested the skin irritation potential of benzotrichloride (CAS n° 98-07-7) on rabbits according to the method described by the Code of Federal Regulations, Title 16, Section 1500.41. Intact and abbraded skin of six New Zealand White rabbits (male/female) were exposed to the test substance for 24h. At the end of exposure (24h) as well as after 72h and 7d, respectively 48h and 6d after ending of exposure, erythema and edema was scored with a system similar to the OECD recommendations. Using the scores obtained for these two parameters, the primary irritation score was calculated which is based on the observations at 24h and 72h.

Under the test conditions, very slight to well-defined erythema and very slight to slight edema was observed at 24h (end of exposure) and 72h (48h after ending exposure) for both intact and abbrated skin. This resulted in a primary irritation score of 2.8 (maximum is 8). Furthermore after 7d the effects of exposure to benzotrichloride were not reversible. Thus, at this level of information benzotrichloride is considered slightly irritating according to the criteria of the Code of Federal Regulation.

GLP standards are not specified. Although only basic information is provided on material and methods, the results are sufficiently described. Hence this study is based on a guideline and no deviations to this methodology are observed, it should therefore be considered as reliable with restrictions, a Klimisch 2.b study, a guideline study with acceptable restrictions.