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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:
23.04.1985 - 07.05.1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
α,2-dichlorotoluene
EC Number:
210-258-8
EC Name:
α,2-dichlorotoluene
Cas Number:
611-19-8
Molecular formula:
C7H6Cl2
IUPAC Name:
1-chloro-2-(chloromethyl)benzene
Details on test material:
Source: HOECHST AG- Code: GLAC 405- Purity: >99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- % coverage:
- Type of wrap if used: semiocclusive bandage


REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: after incubation period


SCORING SYSTEM:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

No necrosis was observed.

======================================================
Animal Symptom     Time after patch removal
No.                -----------------------------------
                   30-60  24    48    72   7   14
                   min    hr    hr    hr   d    d
------------------------------------------------------
1      erythema    1      3     3     4    2    0
       edema       4      1     1     1    0    0
2      erythema    1      3     3     3    1    0
       edema       3      1     1     1    0    0
3      erythema    1      2     2     2    2    0
       edema       2      2     1     1    0    0
======================================================

These results have led to the conclusion that OCBC had no
corrosion effect but had a dermal irritation potential on
the rabbit skin under these study conditions.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information R38: Irritating to skin Criteria used for interpretation of results: EU
Conclusions:
o-Chlorobenzylchloride exhibited an irritating potential.
Executive summary:

In a primary dermal irritation study New Zealand White Rabbits were dermally exposed to 0.5 mL of undiluted o-Chlorobenzylchloride (>99 % a.i.). Test sites at the dorsal flank of the back were covered with a semiocclusive dressing for 4 hours. Then application sites were washed with water. Animals were then observed for 14 days. Irritation was scored according to OECD GL 404. 30 - 60 minutes after removal very slight erythema and slight to severe edema were observed. 24 - 72 hours later severe erythema and slight edema were noticed. Dried skin surface was noticed after 48 hours and after 7 days skin surface was chapped. No necrosis was observed. Development of erythema and edema was completely reversible within 14 days. In this study, o-Chlorbenzylchloride exhibited an irritating potential.